[Code of Federal Regulations]
[Title 21, Volume 8, Parts 800 to 1299]
[Revised as of April 1, 1998]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR866]

[Page 228-262]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

                      Subpart A--General Provisions

Sec.
866.1  Scope.
866.3  Effective dates of requirement for premarket approval.
866.9  Limitations of exemptions from section 510(k) of the Federal 
          Food, Drug, and Cosmetic Act (the act).

                      Subpart B--Diagnostic Devices

866.1620  Antimicrobial susceptibility test disc.
866.1640  Antimicrobial susceptibility test powder.
866.1700  Culture medium for antimicrobial susceptibility tests.

                     Subpart C--Microbiology Devices

866.2050  Staphylococcal typing bacteriophage.
866.2120  Anaerobic chamber.
866.2160  Coagulase plasma.
866.2170  Automated colony counter.
866.2180  Manual colony counter.
866.2300  Multipurpose culture medium.
866.2320  Differential culture medium.
866.2330  Enriched culture medium.
866.2350  Microbiological assay culture medium.
866.2360  Selective culture medium.
866.2390  Transport culture medium.
866.2410  Culture medium for pathogenic Neisseria spp.
866.2420  Oxidase screening test for gonorrhea.
866.2440  Automated medium dispensing and stacking device.
866.2450  Supplement for culture media.
866.2480  Quality control kit for culture media.

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866.2500  Microtiter diluting and dispensing device.
866.2540  Microbiological incubator.
866.2560  Microbial growth monitor.
866.2580  Gas-generating device.
866.2600  Wood's fluorescent lamp.
866.2660  Microorganism differentiation and identification device.
866.2850  Automated zone reader.
866.2900  Microbiological specimen collection and transport device.

                     Subpart D--Serological Reagents

866.3010  Acinetobacter calcoaceticus serological reagents.
866.3020  Adenovirus serological reagents.
866.3035  Arizona spp. serological reagents.
866.3040  Aspergillus spp. serological reagents.
866.3060  Blastomyces dermatitidis serological reagents.
866.3065  Bordetella spp. serological reagents.
866.3085  Brucella spp. serological reagents.
866.3110  Campylobacter fetus serological reagents.
866.3120  Chlamydia serological reagents.
866.3125  Citrobacter spp. serological reagents.
866.3135  Coccidioides immitis serological reagents.
866.3140  Corynebacterium spp. serological reagents.
866.3145  Coxsackievirus serological reagents.
866.3165  Cryptococcus neoformans serological reagents.
866.3175  Cytomegalovirus serological reagents.
866.3200  Echinococcus spp. serological reagents.
866.3205  Echovirus serological reagents.
866.3220  Entamoeba histolytica serological reagents.
866.3235  Epstein-Barr virus serological reagents.
866.3240  Equine encephalomyelitis virus serological reagents.
866.3250  Erysipelothrix rhusiopathiae serological reagents.
866.3255  Escherichia coli serological reagents.
866.3270  Flavobacterium spp. serological reagents.
866.3280  Francisella tularensis serological reagents.
866.3290  Gonococcal antibody test (GAT).
866.3300  Haemophilus spp. serological reagents.
866.3305  Herpes simplex virus serological reagents.
866.3320  Histoplasma capsulatum serological reagents.
866.3330  Influenza virus serological reagents.
866.3340  Klebsiella spp. serological reagents.
866.3350  Leptospira spp. serological reagents.
866.3355  Listeria spp. serological reagents.
866.3360  Lymphocytic choriomeningitis virus serological reagents.
866.3370  Mycobacterium tuberculosis immunofluorescent reagents.
866.3375  Mycoplasma spp. serological reagents.
866.3380  Mumps virus serological reagents.
866.3390  Neisseria spp. direct serological test reagents.
866.3400  Parainfluenza virus serological reagents.
866.3405  Poliovirus serological reagents.
866.3410  Proteus spp. (Weil-Felix) serological reagents.
866.3415  Pseudomonas spp. serological reagents.
866.3460  Rabiesvirus immunofluorescent reagents.
866.3470  Reovirus serological reagents.
866.3480  Respiratory syncytial virus serological reagents.
866.3490  Rhinovirus serological reagents.
866.3500  Rickettsia serological reagents.
866.3510  Rubella virus serological reagents.
866.3520  Rubeola (measles) virus serological reagents.
866.3550  Salmonella spp. serological reagents.
866.3600  Schistosoma spp. serological reagents.
866.3630  Serratia spp. serological reagents.
866.3660  Shigella spp. serological reagents.
866.3680  Sporothrix schenckii serological reagents.
866.3700  Staphylococcus aureus serological reagents.
866.3720  Streptococcus spp. exoenzyme reagents.
866.3740  Streptococcus spp. serological reagents.
866.3780  Toxoplasma gondii serological reagents.
866.3820  Treponema pallidum nontreponemal test reagents.
866.3830  Treponema pallidum treponemal test reagents.
866.3850  Trichinella spiralis serological reagents.
866.3870  Trypanosoma spp. serological reagents.
866.3900  Varicella-zoster virus serological reagents.
866.3930  Vibrio cholerae serological reagents.

         Subpart E--Immunology Laboratory Equipment and Reagents

866.4100  Complement reagent.
866.4500  Immunoelectrophoresis equipment.
866.4520  Immunofluorometer equipment.
866.4540  Immunonephelometer equipment.
866.4600  Ouchterlony agar plate.
866.4800  Radial immunodiffusion plate.
866.4830  Rocket immunoelectrophoresis equipment.
866.4900  Support gel.

                  Subpart F--Immunological Test Systems

866.5040  Albumin immunological test system.

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866.5060  Prealbumin immunological test system.
866.5065  Human allotypic marker immunological test system.
866.5080  Alpha-1-antichymotrypsin immunological test system.
866.5090  Antimitochondrial antibody immunological test system.
866.5100  Antinuclear antibody immunological test system.
866.5110  Antiparietal antibody immunological test system.
866.5120  Antismooth muscle antibody immunological test system.
866.5130  Alpha-1-antitrypsin immunological test system.
866.5150  Bence-Jones proteins immunological test system.
866.5160  Beta-globulin immunological test system.
866.5170  Breast milk immunological test system.
866.5200  Carbonic anhydrase B and C immunological test system.
866.5210  Ceruloplasmin immunological test system.
866.5220  Cohn fraction II immunological test system.
866.5230  Colostrum immunological test system.
866.5240  Complement components immunological test system.
866.5250  Complement C<INF>1</INF> inhibitor (inactivator) immunological 
          test system.
866.5260  Complement C<INF>3b</INF> inactivator immunological test 
          system.
866.5270  C-reactive protein immunological test system.
866.5320  Properidin factor B immunological test system.
866.5330  Factor XIII, A, S, immunological test system.
866.5340  Ferritin immunological test system.
866.5350  Fibrinopeptide A immunological test system.
866.5360  Cohn fraction IV immunological test system.
866.5370  Cohn fraction V immunological test system.
866.5380  Free secretory component immunological test system.
866.5400  Alpha-globulin immunological test system.
866.5420  Alpha-1-glycoproteins immunological test system.
866.5425  Alpha-2-glycoproteins immunological test system.
866.5430  Beta-2-glycoprotein I immunological test system.
866.5440  Beta-2-glycoprotein III immunological test system.
866.5460  Haptoglobin immunological test system.
866.5470  Hemoglobin immunological test system.
866.5490  Hemopexin immunological test system.
866.5500  Hypersensitivity pneumonitis immunological test system.
866.5510  Immunoglobulins A, G, M, D, and E immunological test system.
866.5520  Immunoglobulin G (Fab fragment specific) immunological test 
          system.
866.5530  Immunoglobulin G (Fc fragment specific) immunological test 
          system.
866.5540  Immunoglobulin G (Fd fragment specific) immunological test 
          system.
866.5550  Immunoglobulin (light chain specific) immunological test 
          system.
866.5560  Lactic dehydrogenase immunological test system.
866.5570  Lactoferrin immunological test system.
866.5580  Alpha-1-lipoprotein immunological test system.
866.5590  Lipoprotein X immunological test system.
866.5600  Low-density lipoprotein immunological test system.
866.5620  Alpha-2-macroglobulin immunological test system.
866.5630  Beta-2-microglobulin immunological test system.
866.5640  Infectious mononucleosis immunological test system.
866.5660  Multiple autoantibodies immunological test system.
866.5680  Myoglobin immunological test system.
866.5700  Whole human plasma or serum immunological test system.
866.5715  Plasminogen immunological test system.
866.5735  Prothrombin immunological test system.
866.5750  Radioallergosorbent (RAST) immunological test system.
866.5765  Retinol-binding protein immunological test system.
866.5775  Rheumatoid factor immunological test system.
866.5800  Seminal fluid (sperm) immunological test system.
866.5820  Systemic lupus erythematosus immunological test system.
866.5860  Total spinal fluid immunological test system.
866.5870  Thyroid autoantibody immunological test system.
866.5880  Transferrin immunological test system.
866.5890  Inter-alpha trypsin inhibitor immunological test system.

     Subpart G--Tumor Associated Antigen Immunological Test Systems

866.6010  Tumor associated antigen immunological test system.

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

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    Source:  47 FR 50823, Nov. 9, 1982, unless otherwise noted.

                      Subpart A--General Provisions

Sec. 866.1  Scope.

    (a) This part sets forth the classification of immunology and 
microbiology devices intended for human use that are in commercial 
distribution.
    (b) The indentification of a device in a regulation in this part is 
not a precise description of every device that is, or will be, subject 
to the regulation. A manufacturer who submits a premarket notification 
submission for a device under part 807 may not show merely that the 
device is accurately described by the section title and identification 
provisions of a regulation in this part, but shall state why the device 
is substantially equivalent to other devices, as required by 
Sec. 807.87.
    (c) To avoid duplicative listings, an immunology and microbiology 
device that has two or more types of uses (e.g., used both as a 
diagnostic device and as a microbiology device) is listed only in one 
subpart.
    (d) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.
[52 FR 17733, May 11, 1987]

Sec. 866.3  Effective dates of requirement for premarket approval.

    A device included in this part that is classified into class III 
(Premarket approval) shall not be commercially distributed after the 
date shown in the regulation classifying the device unless the 
manufacturer has an approval under section 515 of the act (unless an 
exemption has been granted under section 520(g)(2) of the act). An 
approval under section 515 of the act consists of FDA's issuance of an 
order approving an application for premarket approval (PMA) for the 
device or declaring completed a product development protocol (PDP) for 
the device.
    (a) Before FDA requires that a device commercially distributed 
before the enactment date of the amendments, or a device that has been 
found substantially equivalent to such a device, has an approval under 
section 515 of the act FDA must promulgate a regulation under section 
515(b) of the act requiring such approval, except as provided in 
paragraphs (b) and (c) of this section. Such a regulation under section 
515(b) of the act shall not be effective during the grace period ending 
on the 90th day after its promulgation or on the last day of the 30th 
full calendar month after the regulation that classifies the device into 
class III is effective, whichever is later. See section 501(f)(2)(B) of 
the act. Accordingly, unless an effective date of the requirement for 
premarket approval is shown in the regulation for a device classified 
into class III in this part, the device may be commercially distributed 
without FDA's issuance of an order approving a PMA or declaring 
completed a PDP for the device. If FDA promulgates a regulation under 
section 515(b) of the act requiring premarket approval for a device, 
section 501(f)(1)(A) of the act applies to the device.
    (b) Any new, not substantially equivalent, device introduced into 
commercial distribution on or after May 28, 1976, including a device 
formerly marketed that has been substantially altered, is classified by 
statute (section 513(f) of the act) into class III without any grace 
period and FDA must have issued an order approving a PMA or declaring 
completed a PDP for the device before the device is commercially 
distributed unless it is reclassified. If FDA knows that a device being 
commercially distributed may be a ``new'' device as defined in this 
section because of any new intended use or other reasons, FDA may codify 
the statutory classification of the device into class III for such new 
use. Accordingly, the regulation for such a class III device states that 
as of the enactment date of the amendments, May 28, 1976, the device 
must have an approval under section 515 of the act before commercial 
distribution.
    (c) A device identified in a regulation in this part that is 
classified into class III and that is subject to the transitional 
provisions of section 520(l) of the act is automatically classified by 
statute into class III and must have an approval under section 515 of 
the act before being commercially distributed. Accordingly, the 
regulation for such a class III transitional device states that

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as of the enactment date of the amendments, May 28, 1976, the device 
must have an approval under section 515 of the act before commercial 
distribution.
[52 FR 17733, May 11, 1987; 52 FR 22577, June 12, 1987]

Sec. 866.9  Limitations of exemptions from section 510(k) of the Federal 
          Food, Drug, and Cosmetic Act (the act).

    The Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 510(k) 
of the act) for a generic type of class I device is based upon the 
existing and reasonably foreseeable characteristics of commercially 
distributed devices within that generic type. Because FDA cannot 
anticipate every change in intended use or characteristic that could 
significantly affect a device's safety or effectiveness, manufacturers 
of any commercially distributed class I device for which FDA has granted 
an exemption from the requirement of premarket notification must still 
submit a premarket notification to FDA before introducing or delivering 
for introduction into interstate commerce for commercial distribution 
the device when:
    (a) The device is intended for a use different from its intended use 
before May 28, 1976, or the device is intended for a use different from 
the intended use of a preamendments device to which it had been 
determined to be substantially equivalent; e.g., the device is intended 
for a different medical purpose, or the device is intended for lay use 
where the former intended use was by health care professionals only; or
    (b) The modified device operates using a different fundamental 
scientific technology than that in use in the device before May 28, 1976 
e.g., a surgical instrument cuts tissue with a laser beam rather than 
with a sharpened metal blade, or an in vitro diagnostic device detects 
or identifies infectious agents by using a deoxyribonucleic acid (DNA) 
probe or nucleic acid hybridization technology rather than culture or 
immunoassay technology.
[54 FR 25045, June 12, 1989]

                      Subpart B--Diagnostic Devices

Sec. 866.1620  Antimicrobial susceptibility test disc.

    (a) Identification. An antimicrobial susceptibility test disc is a 
device that consists of antimicrobic-impregnated paper discs used to 
measure by a disc-agar diffusion technique or a disc-broth elution 
technique the in vitro susceptibility of most clinically important 
bacterial pathogens to antimicrobial agents. In the disc-agar diffusion 
technique, bacterial susceptibility is ascertained by directly measuring 
the magnitude of a zone of bacterial inhibition around the disc on an 
agar surface. The disc-broth elution technique is associated with an 
automated rapid susceptibility test system and employs a fluid medium in 
which susceptibility is ascertained by photometrically measuring changes 
in bacterial growth resulting when antimicrobial material is eluted from 
the disc into the fluid medium. Test results are used to determine the 
antimicrobial agent of choice in the treatment of bacterial diseases.
    (b) Classification. Class II (performance standards).

Sec. 866.1640  Antimicrobial susceptibility test powder.

    (a) Identification. An antimicrobial susceptibility test powder is a 
device that consists of an antimicrobial drug powder packaged in vials 
in specified amounts and intended for use in clinical laboratories for 
determining in vitro susceptibility of bacterial pathogens to these 
therapeutic agents. Test results are used to determine the antimicrobial 
agent of choice in the treatment of bacterial diseases.
    (b) Classification. Class II (performance standards).

Sec. 866.1700  Culture medium for antimicrobial susceptibility tests.

    (a) Identification. A culture medium for antimicrobial 
susceptibility tests is a device intended for medical purposes that 
consists of any medium capable of supporting the growth of many of the 
bacterial pathogens that are subject to antimicrobial susceptibility 
tests. The medium should be free of components known to be antagonistic 
to the common agents for which susceptibility

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tests are performed in the treatment of disease.
    (b) Classification. Class II (performance standards).

                     Subpart C--Microbiology Devices

Sec. 866.2050  Staphylococcal typing bacteriophage.

    (a) Identification. A staphylococcal typing bacteriophage is a 
device consisting of a bacterial virus intended for medical purposes to 
identify pathogenic staphylococcal bacteria through use of the 
bacteria's susceptibility to destruction by the virus. Test results are 
used principally for the collection of epidemiological information.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25045, June 12, 1989]

Sec. 866.2120  Anaerobic chamber.

    (a) Identification. An anaerobic chamber is a device intended for 
medical purposes to maintain an anaerobic (oxygen free) environment. It 
is used to isolate and cultivate anaerobic microorganisms.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807. The 
device also is exempt from the good manufacturing practice regulation in 
part 820, with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.

Sec. 866.2160  Coagulase plasma.

    (a) Identification. Coagulase plasma is a device that consists of 
freeze-dried animal or human plasma that is intended for medical 
purposes to perform coagulase tests primarily on staphylococcal 
bacteria. When reconstituted, the fluid plasma is clotted by the action 
of the enzyme coagulase which is produced by pathogenic staphylococci. 
Test results are used primarily as an aid in the diagnosis of disease 
caused by pathogenic bacteria belonging to the genus Staphylococcus and 
provide epidemiological information on disease caused by these 
microorganisms.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 61 FR 1119, Jan. 16, 1996]

Sec. 866.2170  Automated colony counter.

    (a) Identification. An automated colony counter is a mechanical 
device intended for medical purposes to determine the number of 
bacterial colonies present on a bacteriological culture medium contained 
in a petri plate. The number of colonies counted is used in the 
diagnosis of disease as a measure of the degree of bacterial infection.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25045, June 12, 1989]

Sec. 866.2180  Manual colony counter.

    (a) Identification. A manual colony counter is a device intended for 
medical purposes that consists of a printed grid system superimposed on 
an illuminated screen. Petri plates containing bacterial colonies to be 
counted are placed on the screen for better viewing and ease of 
counting. The number of colonies counted is used in the diagnosis of 
disease as a measure of the degree of bacterial infection.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807. The 
device also is exempt from the good manufacturing practice regulation in 
part 820, with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.

Sec. 866.2300  Multipurpose culture medium.

    (a) Identification. A multipurpose culture medium is a device that 
consists primarily of liquid or solid biological materials intended for 
medical purposes for the cultivation and identification of several types 
of pathogenic microorganisms without the need of

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additional nutritional supplements. Test results aid in the diagnosis of 
disease and also provide epidemiological information on diseases caused 
by these microorganisms.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]

Sec. 866.2320  Differential culture medium.

    (a) Identification. A differential culture medium is a device that 
consists primarily of liquid biological materials intended for medical 
purposes to cultivate and identify different types of pathogenic 
microorganisms. The identification of these microorganisms is 
accomplished by the addition of a specific biochemical component(s) to 
the medium. Microorganisms are identified by a visible change (e.g., a 
color change) in a specific biochemical component(s) which indicates 
that specific metabolic reactions have occurred. Test results aid in the 
diagnosis of disease and also provide epidemiological information on 
diseases caused by these microorganisms.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]

Sec. 866.2330  Enriched culture medium.

    (a) Identification. An enriched culture medium is a device that 
consists primarily of liquid or solid biological materials intended for 
medical purposes to cultivate and identify fastidious microorganisms 
(those having complex nutritional requirements). The device consists of 
a relatively simple basal medium enriched by the addition of such 
nutritional components as blood, blood serum, vitamins, and extracts of 
plant or animal tissues. The device is used in the diagnosis of disease 
caused by pathogenic microorganisms and also provides epidemiological 
information on these diseases.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]

Sec. 866.2350  Microbiological assay culture medium.

    (a) Identification. A microbiological assay culture medium is a 
device that consists primarily of liquid or solid biological materials 
intended for medical purposes to cultivate selected test microorganisms 
in order to measure by microbiological procedures the concentration in a 
patient's serum of certain substances, such as amino acids, 
antimicrobial agents, and vitamins. The concentration of these 
substances is measured by their ability to promote or inhibit the growth 
of the test organism in the innoculated medium. Test results aid in the 
diagnosis of disease resulting from either deficient or excessive 
amounts of these substances in a patient's serum. Tests results may also 
be used to monitor the effects of the administration of certain 
antimicrobial drugs.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]

Sec. 866.2360  Selective culture medium.

    (a) Identification. A selective culture medium is a device that 
consists primarily of liquid or solid biological materials intended for 
medical purposes to cultivate and identify certain pathogenic 
microorganisms. The device contains one or more components that suppress 
the growth of certain microorganisms while either promoting or not 
affecting the growth of other microorganisms. The device aids in the 
diagnosis of disease caused by pathogenic microorganisms and also 
provides epidemiological information on these diseases.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]

[[Page 235]]

Sec. 866.2390  Transport culture medium.

    (a) Identification. A transport culture medium is a device that 
consists of a semisolid, usually non-nutrient, medium that maintains the 
viability of suspected pathogens contained in patient specimens while in 
transit from the specimen collection area to the laboratory. The device 
aids in the diagnosis of disease caused by pathogenic microorganisms and 
also provides epidemiological information on these diseases.
    (b) Classification. Class I (general controls).

Sec. 866.2410  Culture medium for pathogenic Neisseria spp.

    (a) Identification. A culture medium for pathogenic Neisseria spp. 
is a device that consists primarily of liquid or solid biological 
materials used to cultivate and identify pathogenic Neisseria spp. The 
identification aids in the diagnosis of disease caused by bacteria 
belonging to the genus Neisseria, such as epidemic cerebrospinal 
meningitis, other meningococcal disease, and gonorrhea, and also 
provides epidemiological information on these microorganisms.
    (b) Classification. Class II (performance standards).

Sec. 866.2420  Oxidase screening test for gonorrhea.

    (a) Identification. An oxidase screening test for gonorrhea is an in 
vitro device that consists of the articles intended to identify by 
chemical reaction, cytochrome oxidase, an oxidizing enzyme that is 
associated with certain bacteria including Neisseria gonorrhoeae. A 
sample of a male's urethral discharge is obtained on a swab which is 
placed into a wetting agent containing an ingredient that will react 
with cytochrome oxidase. When cytochrome oxidase is present, the swab 
turns a dark purple color within 3 minutes. Because it is unlikely that 
cytochrome oxidase-positive organisms other than Neisseria gonorrhoeae 
are present in the urethral discharge of males, the identification of 
cytochrome oxidase with this device indicates presumptive infection of 
the patient with the causative agent of gonorrhea.
    (b) Classification. Class III (premarket approval) (transitional 
device).
    (c) Date PMA or notice of completion of a PDP is required. As of May 
28, 1976, an approval under section 515 of the act is required before 
this device may be commercially distributed. See Sec. 866.3.
[47 FR 50823, Nov. 9, 1982, as amended at 52 FR 17734, May 11, 1987]

Sec. 866.2440  Automated medium dispensing and stacking device.

    (a) Identification. An automated medium dispensing and stacking 
device is a device intended for medical purposes to dispense a 
microbiological culture medium into petri dishes and then mechanically 
stack the petri dishes.
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807. This device also is exempt from the good manufacturing practice 
regulation in part 820, with the exception of Sec. 820.180, with respect 
to general requirements concerning records, and Sec. 820.198, with 
respect to complaint files.

Sec. 866.2450  Supplement for culture media.

    (a) Identification. A supplement for culture media is a device, such 
as a vitamin or sugar mixture, that is added to a solid or liquid basal 
culture medium to produce a desired formulation and that is intended for 
medical purposes to enhance the growth of fastidious microorganisms 
(those having complex nutritional requirements). This device aids in the 
diagnosis of diseases caused by pathogenic microorganisms.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]

Sec. 866.2480  Quality control kit for culture media.

    (a) Identification. A quality control kit for culture media is a 
device that consists of paper discs (or other suitable materials), each 
impregnated with a specified, freeze-dried, viable microorganism, 
intended for medical purposes to determine if a given culture medium is 
able to support the growth

[[Page 236]]

of that microorganism. The device aids in the diagnosis of disease 
caused by pathogenic microorganisms and also provides epidemiological 
information on these diseases.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]

Sec. 866.2500  Microtiter diluting and dispensing device.

    (a) Identification. A microtiter diluting and dispensing device is a 
mechanical device intended for medical purposes to dispense or serially 
dilute very small quantities of biological or chemical reagents for use 
in various diagnostic procedures.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]

Sec. 866.2540  Microbiological incubator.

    (a) Identification. A microbiological incubator is a device with 
various chambers or water-filled compartments in which controlled 
environmental conditions, particularly temperature, are maintained. It 
is intended for medical purposes to cultivate microorganisms and aid in 
the diagnosis of disease.
    (b) Classification. Class I (general controls). This device is 
exempt from premarket notification procedures in subpart E of part 807. 
The device also is exempt from the good manufacturing practice 
regulation in part 820 with the exception of Sec. 820.180, with respect 
to general requirements concerning records, and Sec. 820.198, with 
respect to complaint files.

Sec. 866.2560  Microbial growth monitor.

    (a) Identification. A microbial growth monitor is a device intended 
for medical purposes that measures the concentration of bacteria 
suspended in a liquid medium by measuring changes in light scattering 
properties, optical density, electrical impedance, or by making direct 
bacterial counts. The device aids in the diagnosis of disease caused by 
pathogenic microorganisms.
    (b) Classification. Class I. With the exception of automated blood 
culturing system devices that are used in testing for bacteria, fungi, 
and other microorganisms in blood and other normally sterile body 
fluids, this device is exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 60 FR 38482, July 27, 1995]

Sec. 866.2580  Gas-generating device.

    (a) Identification. A gas-generating device is a device intended for 
medical purposes that produces predetermined amounts of selected gases 
to be used in a closed chamber in order to establish suitable 
atmospheric conditions for cultivation of microorganisms with special 
atmospheric requirements. The device aids in the diagnosis of disease.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]

Sec. 866.2600  Wood's fluorescent lamp.

    (a) Identification. A Wood's fluorescent lamp is a device intended 
for medical purposes to detect fluorescent materials (e.g., fluorescein 
pigment produced by certain microorganisms) as an aid in the 
identification of these microorganisms. The device aids in the diagnosis 
of disease.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807. The 
device also is exempt from the good manufacturing practice regulation in 
part 820 with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198 with respect to 
complaint files.

Sec. 866.2660  Microorganism differentiation and identification device.

    (a) Identification. A microorganism differentiation and 
identification device is a device intended for medical purposes that 
consists of one or more

[[Page 237]]

components, such as differential culture media, biochemical reagents, 
and paper discs or paper strips impregnated with test reagents, that are 
usually contained in individual compartments and used to differentiate 
and identify selected microorganisms. The device aids in the diagnosis 
of disease.
    (b) Classification. Class I (general controls).

Sec. 866.2850  Automated zone reader.

    (a) Identification. An automated zone reader is a mechanical device 
intended for medical purposes to measure zone diameters of microbial 
growth inhibition (or exhibition), such as those observed on the surface 
of certain culture media used in disc-agar diffusion antimicrobial 
susceptibility tests. The device aids in decisionmaking respecting the 
treatment of disease.
    (b) Classification. Class I (general controls).

Sec. 866.2900  Microbiological specimen collection and transport device.

    (a) Identification. A microbiological specimen collection and 
transport device is a specimen collecting chamber intended for medical 
purposes to preserve the viability or integrity of microorganisms in 
specimens during storage of specimens after their collection and during 
their transport from the collecting area to the laboratory. The device 
may be labeled or otherwise represented as sterile. The device aids in 
the diagnosis of disease caused by pathogenic microorganisms.
    (b) Classification. Class I (general controls).

                     Subpart D--Serological Reagents

Sec. 866.3010  Acinetobacter calcoaceticus serological reagents.

    (a) Identification. Acinetobacter calcoaceticus serological reagents 
are devices that consist of Acinetobacter calcoaceticus antigens and 
antisera used to identify this bacterium from cultured isolates derived 
from clinical specimens. The identification aids in the diagnosis of 
disease caused by the bacterium Acinetobacter calcoaceticus and provides 
epidemiological information on disease caused by this microorganism. 
This organism becomes pathogenic in patients with burns or with 
immunologic deficiency, and infection can result in sepsis (blood 
poisoning).
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]

Sec. 866.3020  Adenovirus serological reagents.

    (a) Identification. Adenovirus serological reagents are devices that 
consist of antigens and antisera used in serological tests to identify 
antibodies to adenovirus in serum. Additionally, some of these reagents 
consist of adenovirus antisera conjugated with a fluorescent dye and are 
used to identify adenoviruses directly from clinical specimens. The 
identification aids in the diagnosis of disease caused by adenoviruses 
and provides epidemiological information on these diseases. Adenovirus 
infections may cause pharyngitis (inflammation of the throat), acute 
respiratory diseases, and certain external diseases of the eye (e.g., 
conjunctivitis).
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]

Sec. 866.3035  Arizona spp. serological reagents.

    (a) Identification. Arizona spp. serological reagents are devices 
that consist of antisera and antigens used to identify Arizona spp. in 
cultured isolates derived from clinical specimens. The identification 
aids in the diagnosis of disease caused by bacteria belonging to the 
genus Arizona and provides epidemiological information on diseases 
caused by these microorganisms. Arizona spp. can cause gastroenteritis 
(food poisoning) and sepsis (blood poisoning).
    (b) Classification. Class I. These devices are exempt from the 
premarket

[[Page 238]]

notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]

Sec. 866.3040  Aspergillus spp. serological reagents.

    (a) Identification. Aspergillus spp. serological reagents are 
devices that consist of antigens and antisera used in various 
serological tests to identify antibodies to Aspergillus spp. in serum. 
The identification aids in the diagnosis of aspergillosis caused by 
fungi belonging to the genus Aspergillus. Aspergillosis is a disease 
marked by inflammatory granulomatous (tumor-like) lessions in the skin, 
ear, eyeball cavity, nasal sinuses, lungs, and occasionally the bones.
    (b) Classification. Class I (general controls).

Sec. 866.3060  Blastomyces dermatitidis serological reagents.

    (a) Identification. Blastomyces dermatitidis serological reagents 
are devices that consist of antigens and antisera used in serological 
tests to identify antibodies to Blastomyces determatitidis in serum. The 
identification aids in the diagnosis of blastomycosis caused by the 
fungus Blastomyces dermatitidis. Blastomycosis is a chronic 
granulomatous (tumor-like) disease, which may be limited to the skin or 
lung or may be widely disseminated in the body resulting in lesions of 
the bones, liver, spleen, and kidneys.
    (b) Classification. Class II (performance standards).

Sec. 866.3065  Bordetella spp. serological reagents.

    (a) Identification. Bordetella spp. serological reagents are devices 
that consist of antigens and antisera, including antisera conjugated 
with a fluorescent dye, used in serological tests to identify Bordetella 
spp. from cultured isolates or directly from clinical specimens. The 
identification aids in the diagnosis of diseases caused by bacteria 
belonging to the genus Bordetella and provides epidemiological 
information on these diseases. Bordetella spp. cause whooping cough 
(Bordetella pertussis) and other similiarly contagious and acute 
respiratory infections characterized by pneumonitis (inflammation of the 
lungs).
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]

Sec. 866.3085  Brucella spp. serological reagents.

    (a) Identification. Brucella spp. serological reagents are devices 
that consist of antigens and antisera used for serological 
identification of Brucella spp. from cultured isolates derived from 
clinical specimens or to identify antibodies to Brucella spp. in serum. 
Additionally, some of these reagents consist of antisera conjugated with 
a fluorescent dye (immunofluorescent reagents) used to identify Brucella 
spp. directly from clinical specimens or cultured isolates derived from 
clinical specimens. The identification aids in the diagnosis of 
brucellosis (e.g., undulant fever, Malta fever) caused by bacteria 
belonging to the genus Brucella and provides epidemiological information 
on diseases caused by these microorganisms.
    (b) Classification. Class II (performance standards).

Sec. 866.3110  Campylobacter fetus serological reagents.

    (a) Identification. Campylobacter fetus serological reagents are 
devices that consist of antisera conjugated with a fluorescent dye used 
to identify Campylobacter fetus from clinical specimens or cultured 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of diseases caused by this bacterium and provides 
epidemiological information on these diseases. Campylobacter fetus is a 
frequent cause of abortion in sheep and cattle and is sometimes 
responsible for endocarditis (inflammation of certain membranes of the 
heart) and enteritis (inflammation of the intestines) in humans.
    (b) Classification. Class I (general controls).

[[Page 239]]

Sec. 866.3120  Chlamydia serological reagents.

    (a) Identification. Chlamydia serological reagents are devices that 
consist of antigens and antisera used in serological tests to identify 
antibodies to chlamydia in serum. Additionally, some of these reagents 
consist of chlamydia antisera conjugated with a fluorescent dye used to 
identify chlamydia directly from clinical specimens or cultured isolates 
derived from clinical specimens. The identification aids in the 
diagnosis of disease caused by bacteria belonging to the genus Chlamydia 
and provides epidemiological information on these diseases. Chlamydia 
are the causative agents of psittacosis (a form of pneumonia), 
lymphogranuloma venereum (a venereal disease), and trachoma (a chronic 
disease of the eye and eyelid).
    (b) Classification. Class I (general controls).

Sec. 866.3125  Citrobacter spp. serological reagents.

    (a) Identification. Citrobacter spp. serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify Citrobacter spp. from cultured isolates derived from 
clinical specimens. The identification aids in the diagnosis of disease 
caused by bacteria belonging to the genus Citrobacter and provides 
epidemiological information on diseases caused by these microorganisms. 
Citrobacter spp. have occasionally been associated with urinary tract 
infections.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]

Sec. 866.3135  Coccidioides immitis serological reagents.

    (a) Identification. Coccidioides immitis serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Coccidioides immitis in serum. The 
identification aids in the diagnosis of coccidioidomycosis caused by a 
fungus belonging to the genus Coccidioides and provides epidemiological 
information on diseases caused by this microorganism. An infection with 
Coccidioides immitis produces symptoms varying in severity from those 
accompanying the common cold to those of influenza.
    (b) Classification. Class II (performance standards).

Sec. 866.3140  Corynebacterium spp. serological reagents.

    (a) Identification. Corynebacterium spp. serological reagents are 
devices that consist of antisera conjugated with a fluorescent dye used 
to identify Corynebacterium spp. from clinical specimens. The 
identification aids in the diagnosis of disease caused by bacteria 
belonging to the genus Corynebacterium and provides epidemiological 
information on diseases caused by these microorganisms. The principal 
human pathogen of this genus, Corynebacterium diphtheriae, causes 
diphtheria. However, many other types of corynebacteria form part of the 
normal flora of the human respiratory tract, other mucus membranes, and 
skin, and are either nonpathogenic or have an uncertain role.
    (b) Classification. Class I (general controls).

Sec. 866.3145  Coxsackievirus serological reagents.

    (a) Identification. Coxsackievirus serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify antibodies to coxsackievirus in serum. Additionally, some of 
these reagents consist of coxsackievirus antisera conjugated with a 
fluorescent dye that are used to identify coxsackievirus from clinical 
specimens or from tissue culture isolates derived from clinical 
specimens. The identification aids in the diagnosis of coxsackievirus 
infections and provides epidemiological information on diseases caused 
by these viruses. Coxsackieviruses produce a variety of infections, 
including common colds, meningitis (inflammation of brain and spinal 
cord membranes), herpangina (brief fever accompanied by ulcerated 
lesions of the throat), and myopericarditis (inflammation of heart 
tissue).
    (b) Classification. Class I (general controls).

[[Page 240]]

Sec. 866.3165  Cryptococcus neoformans serological reagents.

    (a) Identification. Cryptococcus neoformans serological reagents are 
devices that consist of antigens used in serological tests to identify 
antibodies to Cryptococcus neoformans in serum. Additionally, some of 
these reagents consist of antisera conjugated with a fluorescent dye 
(immunofluorescent reagents) and are used to identify Cryptococcus 
neoformans directly from clinical specimens or from cultured isolates 
derived from clinical specimens. The identification aids in the 
diagnosis of cryptococcosis and provides epidemiological information on 
this type of disease. Cryptococcosis infections are found most often as 
chronic meningitis (inflammation of brain membranes) and, if not 
treated, are usually fatal.
    (b) Classification. Class II (performance standards).

Sec. 866.3175  Cytomegalovirus serological reagents.

    (a) Identification. Cytomegalovirus serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify antibodies to cytomegalovirus in serum. The identification aids 
in the diagnosis of diseases caused by cytomegaloviruses (principally 
cytomegalic inclusion disease) and provides epidemiological information 
on these diseases. Cytomegalic inclusion disease is a generalized 
infection of infants and is caused by intrauterine or early postnatal 
infection with the virus. The disease may cause severe congenital 
abnormalities, such as microcephaly (abnormal smallness of the head), 
motor disability, and mental retardation. Cytomegalovirus infection has 
also been associated with acquired hemolytic anemia, acute and chronic 
hepatitis, and an infectious mononucleosis-like syndrome.
    (b) Classification. Class II (performance standards).

Sec. 866.3200  Echinococcus spp. serological reagents.

    (a) Identification. Echinococcus spp. serological reagents are 
devices that consist of Echinococcus spp. antigens and antisera used in 
serological tests to identify antibodies to Echinococcus spp. in serum. 
The identification aids in the diagnosis of echinococcosis, caused by 
parasitic tapeworms belonging to the genus Echinococcus and provides 
epidemiological information on this disease. Echinococcosis is 
characterized by the development of cysts in the liver, lung, kidneys, 
and other organs formed by the larva of the infecting organisms.
    (b) Classification. Class I (general controls).

Sec. 866.3205  Echovirus serological reagents.

    (a) Identification. Echovirus serological reagents are devices that 
consist of antigens and antisera used in serological tests to identify 
antibodies to echovirus in serum. Additionally, some of these reagents 
consist of echovirus antisera conjugated with a fluorescent dye used to 
identify echoviruses from clinical specimens or from tissue culture 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of echovirus infections and provides epidemiological 
information on diseases caused by these viruses. Echoviruses cause 
illnesses such as meningitis (inflammation of the brain and spinal cord 
membranes), febrile illnesses (accompanied by fever) with or without 
rash, and the common cold.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]

Sec. 866.3220  Entamoeba histolytica serological reagents.

    (a) Identification. Entamoeba histolytica serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Entamoeba histolytica in serum. Additionally, 
some of these reagents consist of antisera conjugated with a fluorescent 
dye (immunofluorescent reagents) used to identify Entamoeba histolytica 
directly from clinical specimens. The identification aids in the 
diagnosis of amebiasis caused by the microscopic protozoan parasite 
Entamoeba histolytica and provides epidemiological information

[[Page 241]]

on diseases caused by this parasite. The parasite may invade the skin, 
liver, intestines, lungs, and diaphragm, causing disease conditions such 
as indolent ulcers, an amebic hepatitis, amebic dysentery, and pulmonary 
lesions.
    (b) Classification. Class II (performance standards).
[47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21, 1982]

Sec. 866.3235  Epstein-Barr virus serological reagents.

    (a) Identification. Epstein-Barr virus serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Epstein-Barr virus in serum. The 
identification aids in the diagnosis of Epstein-Barr virus infections 
and provides epidemiological information on diseases caused by these 
viruses. Epstein-Barr viruses are thought to cause infectious 
mononucleosis and have been associated with Burkitt's lymphoma (a tumor 
of the jaw in African children and young adults) and postnasal carcinoma 
(cancer).
    (b) Classification. Class I (general controls).

Sec. 866.3240  Equine encephalomyelitis virus serological reagents.

    (a) Identification. Equine encephalomyelitis virus serological 
reagents are devices that consist of antigens and antisera used in 
serological tests to identify antobodies to equine encephalomyelitis 
virus in serum. The identification aids in the diagnosis of diseases 
caused by equine encephalomyelitis viruses and provides epidemiological 
information on these viruses. Equine encephalomyelitis viruses are 
transmitted to humans by the bite of insects, such as mosquitos and 
ticks, and may cause encephalitis (inflammation of the brain), rash, 
acute arthritis, or hepatitis.
    (b) Classification. Class I (general controls).

Sec. 866.3250  Erysipelothrix rhusiopathiae serological reagents.

    (a) Identification. Erysipelothrix rhusiopathiae serological 
reagents are devices that consist of antigens and antisera used in 
serological tests to identify Erysipelothrix rhusiopathiae from cultured 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of disease caused by this bacterium belonging to the genus 
Erysipelothrix. This organism is responsible for a variety of 
inflammations of the skin following skin abrasions from contact with 
fish, shellfish, or poultry.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]

Sec. 866.3255  Escherichia coli serological reagents.

    (a) Identification. Escherichia coli serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify Escherichia coli from cultured isolates derived from 
clinical specimens. Additionally, some of these reagents consist of 
Escherichia coli antisera conjugated with a fluorescent dye used to 
identify Escherichia coli directly from clinical specimens or cultured 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of diseases caused by this bacterium belonging to the genus 
Escherichia, and provides epidemiological information on diseases caused 
by this microorganism. Although Escherichia coli constitutes the greater 
part of the microorganisms found in the intestinal tract in humans and 
is usually nonpathogenic, those strains which are pathogenic may cause 
urinary tract infections or epidemic diarrheal disease, especially in 
children.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]

Sec. 866.3270  Flavobacterium spp. serological reagents.

    (a) Identification. Flavobacterium spp. serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify Flavobacteriuim spp. from cultured isolates derived from 
clinical specimens. The identification aids in the diagnosis

[[Page 242]]

of disease caused by bacteria belonging to the genus Flavobacterium and 
provides epidemiological information on diseases caused by these 
microorganisms. Most members of this genus are found in soil and water 
and, under certain conditions, may become pathogenic to humans. 
Flavobacterium meningosepticum is highly virulent for the newborn, in 
whom it may cause epidemics of septicemia (blood poisoning) and 
meningitis (inflammation of the membranes of the brain) and is usually 
attributable to contaminated hospital equipment.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]

Sec. 866.3280  Francisella tularensis serological reagents.

    (a) Identification. Francisella tularensis serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Francisella tularensis in serum or to identify 
Francisella tularensis in cultured isolates derived from clinical 
specimens. Additionally, some of these reagents consist of antisera 
conjugated with a fluorescent dye (immunofluorescent reagents) used to 
identify Francisella tularensis directly from clinical specimens. The 
identification aids in the diagnosis of tularemia caused by Francisella 
tularensis and provides epidemiological information on this disease. 
Tularemia is a desease principally of rodents, but may be transmitted to 
humans through handling of infected animals, animal products, or by the 
bites of fleas and ticks. The disease takes on several forms depending 
upon the site of infection, such as skin lesions, lymph node 
enlargements, or pulmonary infection.
    (b) Classification. Class II (performance standards).

Sec. 866.3290  Gonococcal antibody test (GAT).

    (a) Identification. A gonococcal antibody test (GAT) is an in vitro 
device that consists of the reagents intended to identify by 
immunochemical techniques, such as latex agglutination, indirect 
fluorescent antibody, or radioimmunoassay, antibodies to Neisseria 
gonorrhoeae in sera of asymptomatic females at low risk of infection. 
Identification of antibodies with this device may indicate past or 
present infection of the patient with Neisseria gonorrhoeae.
    (b) Classification. Class III (premarket approval) (transitional 
device).
    (c) Date PMA or notice of completion of a PDP is required. As of May 
28, 1976, an approval under section 515 of the act is required before 
this device may be commercially distributed. See Sec. 866.3.
[47 FR 50823, Nov. 9, 1982, as amended at 52 FR 17734, May 11, 1987]

Sec. 866.3300  Haemophilus spp. serological reagents.

    (a) Identification. Haemophilus spp. serological reagents are 
devices that consist of antigens and antisera, including antisera 
conjugated with a fluorescent dye, that are used in serological tests to 
identify Haemophilus spp. directly from clinical specimens or tissue 
culture isolates derived from clinical specimens. The identification 
aids in the diagnosis of diseases caused by bacteria belonging to the 
genus Haemophilus and provides epidemiological information on diseases 
cause by these microorganisms. Diseases most often caused by Haemophilus 
spp. include pneumonia, pharyngitis, sinusitis, vaginitis, chancroid 
venereal disease, and a contagious form of conjunctivitis (inflammation 
of eyelid membranes).
    (b) Classification. Class II (performance standards).

Sec. 866.3305  Herpes simplex virus serological reagents.

    (a) Identification. Herpes simplex virus serological reagents are 
devices that consist of antigens and antisera used in various 
serological tests to identify antibodies to herpes simplex virus in 
serum. Additionally, some of the reagents consist of herpes simplex 
virus antisera conjugated with a fluorescent dye (immunofluorescent 
reagents) used to identify herpes simplex virus directly from clinical 
specimens or tissue culture isolates derived from clinical specimens. 
The identification aids in the diagnosis of diseases caused

[[Page 243]]

by herpes simplex viruses and provides epidemiological information on 
these diseases. Herpes simplex viral infections range from common and 
mild lesions of the skin and mucous membranes to a severe form of 
encephalitis (inflammation of the brain). Neonatal herpes virus 
infections range from an mild infection to a severe generalized disease 
with a fatal outcome.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 866.3.
[47 FR 50823, Nov. 9, 1982, as amended at 52 FR 17734, May 11, 1987]

Sec. 866.3320  Histoplasma capsulatum serological reagents.

    (a) Identification. Histoplasma capsulatum serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Histoplasma capsulatum in serum. Additionally, 
some of these reagents consist of Histoplasma capsulatum antisera 
conjugated with a fluorescent dye (immunofluorescent reagents) used to 
identify Histoplasma capsulatum from clinical specimens or cultured 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of histoplasmosis caused by this fungus belonging to the genus 
Histoplasma and provides epidemiological information on the diseases 
caused by this fungus. Histoplasmosis usually is a mild and often 
asymptomatic respiratory infection, but in a small number of infected 
individuals the lesions may spread to practically all tissues and 
organs.
    (b) Classification. Class II (performance standards).

Sec. 866.3330  Influenza virus serological reagents.

    (a) Identification. Influenza virus serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify antibodies to influenza in serum. The identification aids in 
the diagnosis of influenza (flu) and provides epidemiological 
information on influenza. Influenza is an acute respiratory tract 
disease, which is often epidemic.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]

Sec. 866.3340  Klebsiella spp. serological reagents.

    (a) Identification. Klebsiella spp. serological reagents are devices 
that consist of antigens and antisera, including antisera conjugated 
with a fluorescent dye (immunofluorescent reagents), that are used in 
serological tests to identify Klebsiella spp. from cultured isolates 
derived from clinical specimens. The identification aids in the 
diagnosis of diseases caused by bacteria belonging to the genus 
Klebsiella and provides epidemiological information on these diseases. 
These organisms can cause serious urinary tract and pulmonary 
infections, particularly in hospitalized patients.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]

Sec. 866.3350  Leptospira spp. serological reagents.

    (a) Identification. Leptospira spp. serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify antibodies to Leptospira spp. in serum or identify Leptospira 
spp. from cultured isolates derived from clinical specimens. 
Additionally, some of these antisera are conjugated with a fluorescent 
dye (immunofluorescent reagents) and used to identify Leptospira spp. 
directly from clinical specimens. The identification aids in the 
diagnosis of leptospirosis caused by bacteria belonging to the genus 
Leptospira and provides epidemiological information on this disease. 
Leptospira infections range from mild fever-producing illnesses to 
severe liver and kidney involvement producing hemorrhage and dysfunction 
of these organs.
    (b) Classification. Class II (performance standards).

[[Page 244]]

Sec. 866.3355  Listeria spp. serological reagents.

    (a) Identification. Listeria spp. serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify Listeria spp. from cultured isolates derived from clinical 
specimens. Additionally, some of these reagents consist of Listeria spp. 
antisera conjugated with a fluorescent dye (immunofluorescent reagents) 
used to identify Listeria spp. directly from clinical specimens. The 
identification aids in the diagnosis of listeriosis, a disease caused by 
bacteria belonging to the genus Listeria, and provides epidemiological 
information on diseases caused by these microorganisms. Listeria 
monocytogenes, the most common human pathogen of this genus, causes 
meningitis (inflammation of the brain membranes) and meningoencephalitis 
(inflammation of the brain and brain membranes) and is often fatal if 
untreated. A second form of human listeriosis is an intrauterine 
infection in pregnant women that results in a high mortality rate for 
infants before or after birth.
    (b) Classification. Class I (general controls).

Sec. 866.3360  Lymphocytic choriomeningitis virus serological reagents.

    (a) Identification. Lymphocytic choriomeningitis virus serological 
reagents are devices that consist of antigens and antisera used in 
serological tests to identify antibodies to lymphocytic choriomeningitis 
virus in serum. The identification aids in the diagnosis of lymphocytic 
choriomeningitis virus infections and provides epidemiological 
information on diseases caused by these viruses. Lymphocytic 
choriomeningitis viruses usually cause a mild cerebral meningitis 
(inflammation of membranes that envelop the brain) and occasionally a 
mild pneumonia, but in rare instances may produce severe and even fatal 
illnesses due to complications from cerebral meningitis and pneumonia.
    (b) Classification. Class I (general controls).

Sec. 866.3370  Mycobacterium tuberculosis immunofluorescent reagents.

    (a) Identification. Mycobacterium tuberculosis immunofluorescent 
reagents are devices that consist of antisera conjugated with a 
fluorescent dye used to identify Mycobacterium tuberculosis directly 
from clinical specimens. The identification aids in the diagnosis of 
tuberculosis and provides epidemiological information on this disease. 
Mycobacterium tuberculosis is the common causative organism in human 
tuberculosis, a chronic infectious disease characterized by formation of 
tubercles (small rounded nodules) and tissue necrosis (destruction), 
usually occurring in the lung.
    (b) Classification. Class I (general controls).

Sec. 866.3375  Mycoplasma spp. serological reagents.

    (a) Identification. Mycoplasma spp. serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify antibodies to Mycoplasma spp. in serum. Additionally, some of 
these reagents consist of Mycoplasma spp. antisera conjugated with a 
fluorescent dye (immunofluorescent reagents) used to identify Mycoplasma 
spp. directly from clinical specimens. The identification aids in the 
diagnosis of disease caused by bacteria belonging to the genus 
Mycoplasma and provides epidemiological information on diseases caused 
by these microorganisms. Mycoplasma spp. are associated with 
inflammatory conditions of the urinary and respiratory tracts, the 
genitals, and the mouth. The effects in humans of infection with 
Mycoplasma pneumoniae range from inapparent infection to mild or severe 
upper respiratory disease, ear infection, and bronchial pneumonia.
    (b) Classification. Class I (general controls).

Sec. 866.3380  Mumps virus serological reagents.

    (a) Identification. Mumps virus serological reagents consist of 
antigens and antisera used in serological tests to identify antibodies 
to mumps virus in serum. Additionally, some of these reagents consist of 
antisera conjugated with a fluorescent dye

[[Page 245]]

(immunofluorescent reagents) used in serological tests to identify mumps 
viruses from tissue culture isolates derived from clinical specimens. 
The identification aids in the diagnosis of mumps and provides 
epidemiological information on mumps. Mumps is an acute contagious 
disease, particularly in children, characterized by an enlargement of 
one or both of the parotid glands (glands situated near the ear), 
although other organs may also be involved.
    (b) Classification. Class I (general controls).

Sec. 886.3390  Neisseria spp. direct serological test reagents.

    (a) Identification. Neisseria spp. direct serological test reagents 
are devices that consist of antigens and antisera used in serological 
tests to identify Neisseria spp. from cultured isolates. Additionally, 
some of these reagents consist of Neisseria spp. antisera conjugated 
with a fluorescent dye (immunofluorescent reagents) which may be used to 
detect the presence of Neisseria spp. directly from clinical specimens. 
The identification aids in the diagnosis of disease caused by bacteria 
belonging to the genus Neisseria, such as epidemic cerebrospinal 
meningitis, meningococcal disease, and gonorrhea, and also provides 
epidemiological information on diseases caused by these microorganisms. 
The device does not include products for the detection of gonorrhea in 
humans by indirect methods, such as detection of antibodies or of 
oxidase produced by gonococcal organisms.
    (b) Classification. Class II (performance standards).

Sec. 866.3400  Parainfluenza virus serological reagents.

    (a) Identification. Parainfluenza virus serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to parainfluenza virus in serum. The 
identification aids in the diagnosis of parainfluenza virus infections 
and provides epidemiological information on diseases caused by these 
viruses. Parainfluenza viruses cause a variety of respiratory illnesses 
ranging from the common cold to pneumonia.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]

Sec. 866.3405  Poliovirus serological reagents.

    (a) Identification. Poliovirus serological reagents are devices that 
consist of antigens and antisera used in serological tests to identify 
antibodies to poliovirus in serum. Additionally, some of these reagents 
consist of poliovirus antisera conjugated with a fluorescent dye 
(immunofluorescent reagents) used to identify polioviruses from clinical 
specimens or from tissue culture isolates derived from clinical 
specimens. The identification aids in the diagnosis of poliomyelitis 
(polio) and provides epidemiological information on this disease. 
Poliomyelitis is an acute infectious disease which in its serious form 
affects the central nervous system resulting in atrophy (wasting away) 
of groups of muscles, ending in contraction and permanent deformity.
    (b) Classification. Class I (general controls).

Sec. 866.3410  Proteus spp. (Weil-Felix) serological reagents.

    (a) Identification. Proteus spp. (Weil-Felix) serological reagents 
are devices that consist of antigens and antisera, including antisera 
conjugated with a fluorescent dye (immunofluorescent reagents), derived 
from the bacterium Proteus vulgaris used in agglutination tests (a 
specific type of antigen-antibody reaction) for the detection of 
antibodies to rickettsia (virus-like bacteria) in serum. Test results 
aid in the diagnosis of diseases caused by bacteria belonging to the 
genus Rickettsiae and provide epidemiological information on these 
diseases. Rickettsia are generally transmitted by arthropods (e.g., 
ticks and mosquitoes) and produce infections in humans characterized by 
rash and fever (e.g., typhus fever, spotted fever, Q fever, and trench 
fever).
    (b) Classification. Class I. These devices are exempt from the 
premarket

[[Page 246]]

notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]

Sec. 866.3415  Pseudomonas spp. serological reagents.

    (a) Identification. Pseudomonas spp. serological reagents are 
devices that consist of antigens and antisera, including antisera 
conjugated with a fluorescent dye (immunofluorescent reagents), used to 
identify Pseudomonas spp. from clinical specimens or from cultured 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of disease caused by bacteria belonging to the genus 
Pseudomonas. Pseudomonas aeruginosa is a major cause of hospital-
acquired infections, and has been associated with urinary tract 
infections, eye infections, burn and wound infections, blood poisoning, 
abscesses, and meningitis (inflammation of brain membranes). Pseudomonas 
pseudomallei causes melioidosis, a chronic pneumonia.
    (b) Classification. Class II (performance standards).

Sec. 866.3460  Rabiesvirus immunofluorescent reagents.

    (a) Identification. Rabiesvirus immunofluorescent reagents are 
devices that consist of rabiesvirus antisera conjugated with a 
fluorescent dye used to identify rabiesvirus in specimens taken from 
suspected rabid animals. The identification aids in the diagnosis of 
rabies in patients exposed by animal bites and provides epidemiological 
information on rabies. Rabies is an acute infectious disease of the 
central nervous system which, if undiagnosed, may be fatal. The disease 
is commonly transmitted to humans by a bite from a rabid animal.
    (b) Classification. Class II (performance standards).

Sec. 866.3470  Reovirus serological reagents.

    (a) Identification. Reovirus serological reagents are devices that 
consist of antigens and antisera used in serological tests to identify 
antibodies to reovirus in serum. The identification aids in the 
diagnosis of reovirus infections and provides epidemiological 
information on diseases caused by these viruses. Reoviruses are thought 
to cause only mild respiratory and gastrointestinal illnesses.
    (b) Classification. Class I. These devices are exempt from premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]

Sec. 866.3480  Respiratory syncytial virus serological reagents.

    (a) Identification. Respiratory syncytial virus serological reagents 
are devices that consist of antigens and antisera used in serological 
tests to identify antibodies to respiratory syncytial virus in serum. 
Additionally, some of these reagents consist of respiratory syncytial 
virus antisera conjugated with a fluorescent dye (immunofluorescent 
reagents) and used to identify respiratory syncytial viruses from 
clinical specimens or from tissue culture isolates derived from clinical 
specimens. The identification aids in the diagnosis of respiratory 
syncytial virus infections and provides epidemiological information on 
diseases caused by these viruses. Respiratory syncytial viruses cause a 
number of respiratory tract infections, including the common cold, 
pharyngitis, and infantile bronchopneumonia.
    (b) Classification. Class I (general controls).

Sec. 866.3490  Rhinovirus serological reagents.

    (a) Identification. Rhinovirus serological reagents are devices that 
consist of antigens and antisera used in serological tests to identify 
antibodies to rhinovirus in serum. The identification aids in the 
diagnosis of rhinovirus infections and provides epidemiological 
information on diseases caused by these viruses. Rhinoviruses cause 
common colds.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]

[[Page 247]]

Sec. 866.3500  Rickettsia serological reagents.

    (a) Identification. Rickettsia serological reagents are devices that 
consist of antigens and antisera used in serological tests to identify 
antibodies to rickettsia in serum. Additionally, some of these reagents 
consist of rickettsial antisera conjugated with a fluorescent dye 
(immunofluorescent reagents) used to identify rickettsia directly from 
clinical specimens. The identification aids in the diagnosis of diseases 
caused by virus-like bacteria belonging to the genus Rickettsiae and 
provides epidemiological information on these diseases. Rickettsia are 
generally transmitted by arthropods (e.g., ticks and mosquitoes) and 
produce infections in humans characterized by rash and fever (e.g., 
typhus fever, spotted fever, Q fever, and trench fever).
    (b) Classification. Class I (general controls).

Sec. 866.3510  Rubella virus serological reagents.

    (a) Identification. Rubella virus serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify antibodies to rubella virus in serum. The identification aids 
in the diagnosis of rubella (German measles) or confirmation of a 
person's immune status from past infections or immunizations and 
provides epidemiological information on German measles. Newborns 
infected in the uterus with rubella virus may be born with multiple 
congenital defects (rubella syndrome).
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 866.3.
[47 FR 50823, Nov. 9, 1982, as amended at 52 FR 17734, May 11, 1987]

Sec. 866.3520  Rubeola (measles) virus serological reagents.

    (a) Identification. Rubeola (measles) virus serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to rubeola virus in serum. The identification 
aids in the diagnosis of measles and provides epidemiological 
information on the disease. Measles is an acute, highly infectious 
disease of the respiratory and reticuloendothelial tissues, particularly 
in children, characterized by a confluent and blotchy rash.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]

Sec. 866.3550  Salmonella spp. serological reagents.

    (a) Identification. Salmonella spp. serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify Salmonella spp. from cultured isolates derived from clinical 
specimens. Additionally, some of these reagents consist of antisera 
conjugated with a fluorescent dye (immunofluorescent reagents) used to 
identify Salmonella spp. directly from clinical specimens or cultured 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of salmonellosis caused by bacteria belonging to the genus 
Salmonella and provides epidemiological information on this disease. 
Salmonellosis is characterized by high grade fever (``enteric fever''), 
severe diarrhea, and cramps.
    (b) Classification. Class II (performance standards).

Sec. 866.3600  Schistosoma spp. serological reagents.

    (a) Identification. Schistosoma spp. serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Schistosoma spp. in serum. The identification 
aids in the diagnosis of schistosomiasis caused by parasitic flatworms 
of the genus Schistosoma. Schistosomiasis is characterized by a variety 
of acute and chronic infections. Acute infection is marked by fever, 
allergic symptoms, and diarrhea. Chronic effects are usually severe and 
are caused by fibrous degeneration of tissue around deposited eggs of 
the parasite in the liver, lungs, and central nervous system. 
Schistosomes can also cause schistosome dermatitis (e.g.,

[[Page 248]]

swimmer's itch), a skin disease marked by intense itching.
    (b) Classification. Class I (general controls).

Sec. 866.3630  Serratia spp. serological reagents.

    (a) Identification. Serratia spp. serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify Serratia spp. from cultured isolates. The identification aids 
in the diagnosis of disease caused by bacteria belonging to the genus 
Serratia and provides epidemiological information on these diseases. 
Serratia spp. are occasionally associated with gastroenteritis (food 
poisoning) and wound infections.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982 as amended at 54 FR 25047, June 12, 1989]

Sec. 866.3660  Shigella spp. serological reagents.

    (a) Identification. Shigella spp. serological reagents are devices 
that consist of antigens and antisera, including antisera conjugated 
with a fluorescent dye (immunofluorescent reagents), used in serological 
tests to identify Shigella spp. from cultured isolates. The 
identification aids in the diagnosis of shigellosis caused by bacteria 
belonging to the genus Shigella and provides epidemiological information 
on this disease. Shigellosis is characterized by abdominal pain, cramps, 
diarrhea, and fever.
    (b) Classification. Class II (performance standards).

Sec. 866.3680  Sporothrix schenckii serological reagents.

    (a) Identification. Sporothrix schenckii serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Sporothrix schenckii in serum. The 
identification aids in the diagnosis of sporothrichosis caused by a 
fungus belonging to the genus Sporothrix and provides epidemiological 
information on this disease. Sporothrichosis is a chronic tumorlike 
infection primarily of the skin.
    (b) Classification. Class I (general controls).

Sec. 866.3700  Staphylococcus aureus serological reagents.

    (a) Identification. Staphylococcus aureus serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify enterotoxin (toxin affecting the intestine) producing 
staphylococci from cultured isolates. The identification aids in the 
diagnosis of disease caused by this bacterium belonging to the genus 
Staphylococcus and provides epidemiological information on these 
diseases. Certain strains of Staphylococcus aureus produce an 
enterotoxin while growing in meat, dairy, or bakery products. After 
ingestion, this enterotoxin is absorbed in the gut and causes 
destruction of the intestinal lining (gastroenteritis).
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]

Sec. 866.3720  Streptococcus spp. exoenzyme reagents.

    (a) Identification. Streptococcus spp. exoenzyme reagents are 
devices used to identify antibodies to Streptococcus spp. exoenzyme in 
serum. The identification aids in the diagnosis of disease caused by 
bacteria belonging to the genus Streptococcus and provides 
epidemiological information on these diseases. Pathogenic streptococci 
are associated with infections, such as sore throat, impetigo (an 
infection characterized by small pustules on the skin), urinary tract 
infections, rheumatic fever, and kidney disease.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 61 FR 1119, Jan. 16, 1996]

Sec. 866.3740  Streptococcus spp. serological reagents.

    (a) Identification. Streptococcus spp. serological reagents are 
devices that

[[Page 249]]

consist of antigens and antisera (excluding streptococcal exoenzyme 
reagents made from enzymes secreted by streptococci) used in serological 
tests to identify Streptococcus spp. from cultured isolates derived from 
clinical specimens. The identification aids in the diagnosis of diseases 
caused by bacteria belonging to the genus Streptococcus and provides 
epidemiological information on these diseases. Pathogenic streptococci 
are associated with infections, such as sore throat, impetigo (an 
infection characterized by small pustules on the skin), urinary tract 
infections, rheumatic fever, and kidney disease.
    (b) Classification. Class I (general controls).

Sec. 866.3780  Toxoplasma gondii serological reagents.

    (a) Identification. Toxoplasma gondii serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Toxoplasma gondii in serum. Additionally, some 
of these reagents consist of antisera conjugated with a fluorescent dye 
(immunofluorescent reagents) used to identify Toxoplasma gondii from 
clinical specimens. The identification aids in the diagnosis of 
toxoplasmosis caused by the parasitic protozoan Toxoplasma gondii and 
provides epidemiological information on this disease. Congenital 
toxoplasmosis is characterized by lesions of the central nervous system, 
which if undetected and untreated may lead to brain defects, blindness, 
and death of an unborn fetus. The disease is characterized in children 
by inflammation of the brain and spinal cord.
    (b) Classification. Class II (performance standards).

Sec. 866.3820  Treponema pallidum nontreponemal test reagents.

    (a) Identification. Treponema pallidum nontreponemal test reagents 
are devices that consist of antigens derived from nontreponemal sources 
(sources not directly associated with treponemal organisms) and control 
sera (standardized sera with which test results are compared) used in 
serological tests to identify reagin, an antibody-like agent, which is 
produced from the reaction of treponema microorganisms with body 
tissues. The identification aids in the diagnosis of syphilis caused by 
microorganisms belonging to the genus Treponema and provides 
epidemiological information on syphilis.
    (b) Classification. Class II (performance standards).

Sec. 866.3830  Treponema pallidum treponemal test reagents.

    (a) Identification. Treponema pallidum treponemal test reagents are 
devices that consist of the antigens, antisera and all control reagents 
(standardized reagents with which test results are compared) which are 
derived from treponemal sources and that are used in the fluorescent 
treponemal antibody absorption test (FTA-ABS), the Treponema pallidum 
immobilization test (T.P.I.), and other treponemal tests used to 
identify antibodies to Treponema pallidum directly from infecting 
treponemal organisms in serum. The identification aids in the diagnosis 
of syphilis caused by bacteria belonging to the genus Treponema and 
provides epidemiological information on syphilis.
    (b) Classification. Class II (performance standards).

Sec. 866.3850  Trichinella spiralis serological reagents.

    (a) Identification. Trichinella spiralis serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Trichinella spiralis in serum. The 
identification aids in the diagnosis of trichinosis caused by parasitic 
roundworms belonging to the genus Trichinella and provides 
epidemiological information on trichinosis. Trichinosis is caused by 
ingestion of undercooked, infested meat, especially pork, and 
characterized by fever, muscle weakness, and diarrhea.
    (b) Classification. Class I (general controls).

Sec. 866.3870  Trypanosoma spp. serological reagents.

    (a) Identification. Trypanosoma spp. serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies

[[Page 250]]

to Trypanosoma spp. in serum. The identification aids in the diagnosis 
of trypanosomiasis, a disease caused by parasitic protozoans belonging 
to the genus Trypanosoma. Trypanosomiasis in adults is a chronic disease 
characterized by fever, chills, headache, and vomiting. Central nervous 
system involvement produces typical sleeping sickness syndrome: physical 
exhaustion, inability to eat, tissue wasting, and eventual death. Chagas 
disease, an acute form of trypanosomiasis in children, most seriously 
affects the central nervous system and heart muscle.
    (b) Classification. Class I (general controls).

Sec. 866.3900  Varicella-zoster virus serological reagents.

    (a) Identification. Varicella-zoster virus serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to varicella-zoster in serum. The identification 
aids in the diagnosis of diseases caused by varicella-zoster viruses and 
provides epidemiological information on these diseases. Varicella 
(chicken pox) is a mild, highly infectious disease, chiefly of children. 
Zoster (shingles) is the recurrent form of the disease, occurring in 
adults who were previously infected with varicella-zoster viruses. 
Zoster is the response (characterized by a rash) of the partially immune 
host to a reactivation of varicella viruses present in latent form in 
the patient's body.
    (b) Classification. Class II (performance standards).

Sec. 866.3930  Vibrio cholerae serological reagents.

    (a) Identification. Vibrio cholerae serological reagents are devices 
that are used in the agglutination (an antigen-antibody clumping 
reaction) test to identify Vibrio cholerae from cultured isolates 
derived from clinical specimens. The identification aids in the 
diagnosis of cholera caused by the bacterium Vibrio cholerae and 
provides epidemiological information on cholera. Cholera is an acute 
infectious disease characterized by severe diarrhea with extreme fluid 
and electrolyte (salts) depletion, and by vomiting, muscle cramps, and 
prostration. If untreated, the severe dehydration may lead to shock, 
renal failure, cardiovascular collapse, and death.
    (b) Classification. Class II (performance standards).

         Subpart E--Immunology Laboratory Equipment and Reagents

Sec. 866.4100  Complement reagent.

    (a) Identification. A complement reagent is a device that consists 
of complement, a naturally occurring serum protein from any warm-blooded 
animal such as guinea pigs, that may be included as a component part of 
serological test kits used in the diagnosis of disease.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807.

Sec. 866.4500  Immunoelectrophoresis equipment.

    (a) Identification. Immunoelectrophoresis equipment for clinical use 
with its electrical power supply is a device used for separating protein 
molecules. Immunoelectrophoresis is a procedure in which a complex 
protein mixture is placed in an agar gel and the various proteins are 
separated on the basis of their relative mobilities under the influence 
of an electric current. The separated proteins are then permitted to 
diffuse through the agar toward a multispecific antiserum, allowing 
precipitation and visualization of the separate complexes.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]

Sec. 866.4520  Immunofluorometer equipment.

    (a) Identification. Immunofluorometer equipment for clinical use 
with its electrical power supply is a device used to measure the 
fluorescence of fluorochrome-labeled antigen-antibody complexes. The 
concentration of these complexes may be measured by means of reflected 
light. A beam of light is passed through a solution in which a

[[Page 251]]

fluorochrome has been selectively attached to serum protein antibody 
molecules in suspension. The amount of light emitted by the fluorochrome 
label is detected by a photodetector, which converts light energy into 
electrical energy. The amount of electrical energy registers on a 
readout system such as a digital voltmeter or a recording chart. This 
electrical readout is called the fluorescence value and is used to 
measure the concentration of antigen-antibody complexes.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]

Sec. 866.4540  Immunonephelometer equipment.

    (a) Identification. Immunonephelometer equipment for clinical use 
with its electrical power supply is a device that measures light 
scattering from antigen-antibody complexes. The concentration of these 
complexes may be measured by means of reflected light. A beam of light 
passed through a solution is scattered by the particles in suspension. 
The amount of light is detected by a photodetector, which converts light 
energy into electrical energy. The amount of electrical energy registers 
on a readout system such as a digital voltmeter or a recording chart. 
This electrical readout is called the light-scattering value and is used 
to measure the concentration of antigen-antibody complexes. This generic 
type of device includes devices with various kinds of light sources, 
such as laser equipment.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]

Sec. 866.4600  Ouchterlony agar plate.

    (a) Identification. An ouchterlony agar plate for clinical use is a 
device containing an agar gel used to examine antigen-antibody 
reactions. In immunodiffusion, antibodies and antigens migrate toward 
each other through gel which originally contained neither of these 
reagents. As the reagents come in contact with each other, they combine 
to form a precipitate that is trapped in the gel matrix and is 
immobilized.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]

Sec. 866.4800  Radial immunodiffusion plate.

    (a) Identification. A radial immunodiffusion plate for clinical use 
is a device that consists of a plastic plate to which agar gel 
containing antiserum is added. In radial immunodiffusion, antigens 
migrate through gel which originally contains specific antibodies. As 
the reagents come in contact with each other, they combine to form a 
precipitate that is trapped in the gel matrix and immobilized.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807.

Sec. 866.4830  Rocket immunoelectrophoresis equipment.

    (a) Identification. Rocket immunoelectrophoresis equipment for 
clinical use is a device used to perform a specific test on proteins by 
using a procedure called rocket immunoelectrophoresis. In this 
procedure, an electric current causes the protein in solution to migrate 
through agar gel containing specific antisera. The protein precipitates 
with the antisera in a rocket-shaped pattern, giving the name to the 
device. The height of the peak (or the area under the peak) is 
proportional to the concentration of the protein.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]

[[Page 252]]

Sec. 866.4900  Support gel.

    (a) Identification. A support gel for clinical use is a device that 
consists of an agar or agarose preparation that is used while measuring 
various kinds of, or parts of, protein molecules by various 
immunochemical techniques, such as immunoelectrophoresis, 
immunodiffusion, or chromatography.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]

                  Subpart F--Immunological Test Systems

Sec. 866.5040  Albumin immunological test system.

    (a) Identification. An albumin immunological test system is a device 
that consists of the reagents used to measure by immunochemical 
techniques the albumin (a plasma protein) in serum and other body 
fluids. Measurement of albumin aids in the diagnosis of kidney and 
intestinal diseases.
    (b) Classification. Class II (performance standards).

Sec. 866.5060  Prealbumin immunological test system.

    (a) Identification. A prealbumin immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the prealbumin (a plasma protein) in serum and other body 
fluids. Measurement of prealbumin levels in serum may aid in the 
assessment of the patient's nutritional status.
    (b) Classification. Class I (general controls).

Sec. 866.5065  Human allotypic marker immunological test system.

    (a) Identification. A human allotypic marker immunological test 
system is a device that consists of the reagents used to identify by 
immunochemical techniques the inherited human protein allotypic markers 
(such as nGm, nA<INF>2</INF> m, and Km allotypes) in serum and other 
body fluids. The identification may be used while studying population 
genetics.
    (b) Classification. Class I (general controls).

Sec. 866.5080  Alpha-1-antichymotrypsin immunological test system.

    (a) Identification. An alpha-1-antichymotrypsin immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques alpha-1-antichymotrypsin (a protein) in serum, 
other body fluids, and tissues. Alpha-1-antichymotrypsin helps protect 
tissues against proteolytic (protein-splitting) enzymes released during 
infection.
    (b) Classification. Class II (performance standards).

Sec. 866.5090  Antimitochondrial antibody immunological test system.

    (a) Identification. An antimitochondrial antibody immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the antimitochondrial antibodies in human 
serum. The measurements aid in the diagnosis of diseases that produce a 
spectrum of autoantibodies (antibodies produced against the body's own 
tissue), such as primary biliary cirrhosis (degeneration of liver 
tissue) and chronic active hepatitis (inflammation of the liver).
    (b) Classification. Class II (performance standards).

Sec. 866.5100  Antinuclear antibody immunological test system.

    (a) Identification. An antinuclear antibody immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the autoimmune antibodies in serum, other body 
fluids, and tissues that react with cellular nuclear constituents 
(molecules present in the nucleus of a cell, such as ribonucleic acid, 
deoxyribonucleic acid, or nuclear proteins). The measurements aid in the 
diagnosis of systemic lupus erythematosus (a multisystem autoimmune 
disease in which antibodies attack the victim's own tissues), hepatitis 
(a liver disease), rheumatoid arthritis, Sjogren's syndrome (arthritis 
with inflammation of the eye, eyelid,

[[Page 253]]

and salivary glands), and systemic sclerosis (chronic hardening and 
shrinking of many body tissues).
    (b) Classification. Class II (performance standards).

Sec. 866.5110  Antiparietal antibody immunological test system.

    (a) Identification. An antiparietal antibody immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the specific antibody for gastric parietal 
cells in serum and other body fluids. Gastric parietal cells are those 
cells located in the stomach that produce a protein that enables vitamin 
B<INF>12</INF> to be absorbed by the body. The measurements aid in the 
diagnosis of vitamin B<INF>12</INF> deficiency (or pernicious anemia), 
atrophic gastritis (inflammation of the stomach), and autoimmune 
connective tissue diseases (diseases resulting when the body produces 
antibodies against its own tissues).
    (b) Classification. Class II (performance standards).

Sec. 866.5120  Antismooth muscle antibody immunological test system.

    (a) Identification. An antismooth muscle antibody immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the antismooth muscle antibodies (antibodies 
to nonstriated, involuntary muscle) in serum. The measurements aid in 
the diagnosis of chronic hepatitis (inflammation of the liver) and 
autoimmune connective tissue diseases (diseases resulting from 
antibodies produced against the body's own tissues).
    (b) Classification Class II (performance standards).

Sec. 866.5130  Alpha-1-antitrypsin immunological test system.

    (a) Identification. An alpha-1-antitrypsin immunological test system 
is a device that consists of the reagents used to measure by 
immunochemical techniques the alpha-1-antitrypsin (a plasma protein) in 
serum, other body fluids, and tissues. The measurements aid in the 
diagnosis of several conditions including juvenile and adult cirrhosis 
of the liver. In addition, alpha-1-antitrypsin deficiency has been 
associated with pulmonary emphysema.
    (b) Classification. Class II (performance standards).

Sec. 866.5150  Bence-Jones proteins immunological test system.

    (a) Identification. A Bence-Jones proteins immunological test system 
is a device that consists of the reagents used to measure by 
immunochemical techniques the Bence-Jones proteins in urine and plasma. 
Immunoglobulin molecules normally consist of pairs of polypeptide chains 
(subunits) of unequal size (light chains and heavy chains) bound 
together by several disulfide bridges. In some cancerous conditions, 
there is a proliferation of one plasma cell (antibody-producing cell) 
with excess production of light chains of one specific kind (monoclonal 
light chains). These free homogeneous light chains not associated with 
an immunoglobulin molecule can be found in urine and plasma, and have 
been called Bence-Jones proteins. Measurement of Bence-Jones proteins 
and determination that they are monoclonal aid in the diagnosis of 
multiple myeloma (malignant proliferation of plasma cells), 
Waldenstrom's macroglobulinemia (increased production of large 
immunoglobulins by spleen and bone marrow cells), leukemia (cancer of 
the blood-forming organs), and lymphoma (cancer of the lymphoid tissue).
    (b) Classification. Class II (performance standards).

Sec. 866.5160  Beta-globulin immunological test system.

    (a) Identification. A beta-globulin immunological test system is a 
device that consists of reagents used to measure by immunochemical 
techniques beta globulins (serum protein) in serum and other body 
fluids. Beta-globulin proteins include beta-lipoprotein, transferrin, 
glycoproteins, and complement, and are rarely associated with specific 
pathologic disorders.
    (b) Classification. Class I (general controls).

[[Page 254]]

Sec. 866.5170  Breast milk immunological test system.

    (a) Identification. A breast milk immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the breast milk proteins.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 59 FR 63007, Dec. 7, 1994]

Sec. 866.5200  Carbonic anhydrase B and C immunological test system.

    (a) Identification. A carbonic anhydrase B and C immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques specific carbonic anhydrase protein molecules 
in serum and other body fluids. Measurements of carbonic anhydrase B and 
C aid in the diagnosis of abnormal hemoglobin metabolism.
    (b) Classification. Class I (general controls).

Sec. 866.5210  Ceruloplasmin immunological test system.

    (a) Identification. A ceruloplasmin immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the ceruloplasmin (copper-transporting serum protein) in 
serum, other body fluids, or tissues. Measurements of ceruloplasmin aid 
in the diagnosis of copper metabolism disorders.
    (b) Classification. Class II (performance standards).

Sec. 866.5220  Cohn fraction II immunological test system.

    (a) Identification. A Cohn fraction II immunological test system is 
a device that consists of the reagents that contain or are used to 
measure that fraction of plasma containing protein gamma globulins, 
predominantly of the IgG class. The device may be used as a 
coprecipitant in radioimmunoassay methods, as raw material for the 
purification of IgG subclasses, and to reduce nonspecific adsorption of 
plasma proteins in immunoassay techniques. Measurement of these proteins 
aids in the diagnosis of any disease concerned with abnormal levels of 
IgG gamma globulins such as agammaglobulinemia or multiple myeloma.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 59 FR 63007, Dec. 7, 1994]

Sec. 866.5230  Colostrum immunological test system.

    (a) Identification. A colostrum immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the specific proteins in colostrum. Colostrum is a substance 
excreted by the mammary glands during pregnancy and until production of 
breast milk begins 1 to 5 days after childbirth.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 59 FR 63007, Dec. 7, 1994]

Sec. 866.5240  Complement components immunological test system.

    (a) Identification. A complement components immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques complement components C<INF>1q</INF>, 
C<INF>1r</INF>, C<INF>1s</INF>, C<INF>2</INF>, C<INF>3</INF>, 
C<INF>4</INF>, C<INF>5</INF>, C<INF>6</INF>, C<INF>7</INF>, 
C<INF>8</INF>, and C<INF>9</INF>, in serum, other body fluids, and 
tissues. Complement is a group of serum proteins which destroy 
infectious agents. Measurements of these proteins aids in the diagnosis 
of immunologic disorders, especially those associated with deficiencies 
of complement components.
    (b) Classification. Class II (performance standards).
[47 FR 50823, Nov. 9, 1982, as amended at 53 FR 11253, Apr. 6, 1988]

Sec. 866.5250  Complement C<INF>1</INF> inhibitor (inactivator) 
          immunological test system.

    (a) Identification. A complement C<INF>1</INF> inhibitor 
(inactivator) immunological test system is a device that consists of the 
reagents used to measure by

[[Page 255]]

immunochemical techniques the complement C<INF>1</INF> inhibitor (a 
plasma protein) in serum. Complement C<INF>1</INF> inhibitor occurs 
normally in plasma and blocks the action of the C<INF>1</INF> component 
of complement (a group of serum proteins which destroy infectious 
agents). Measurement of complement C<INF>1</INF> inhibitor aids in the 
diagnosis of hereditary angioneurotic edema (increased blood vessel 
permeability causing swelling of tissues) and a rare form of angioedema 
associated with lymphoma (lymph node cancer).
    (b) Classification. Class II (performance standards).

Sec. 866.5260  Complement C<INF>3b</INF> inactivator immunological test 
          system.

    (a) Identification. A complement C<INF>3b</INF> inactivator 
immunological test system is a device that consists of the reagents used 
to measure by immunochemical techniques the complement C<INF>3b</INF> 
inactivator (a plasma protein) in serum. Complement is a group of serum 
proteins that destroy infectious agents. Measurement of complement 
C<INF>3b</INF> inactivator aids in the diagnosis of inherited antibody 
dysfunction.
    (b) Classification. Class II (performance standards).

Sec. 866.5270  C-reactive protein immunological test system.

    (a) Identification. A C-reactive protein immunological test system 
is a device that consists of the reagents used to measure by 
immunochemical techniques the C-reactive protein in serum and other body 
fluids. Measurement of C-reactive protein aids in evaluation of the 
amount of injury to body tissues.
    (b) Classification. Class II (performance standards).

Sec. 866.5320  Properdin factor B immunological test system.

    (a) Identification. A properdin factor B immunological test system 
is a device that consists of the reagents used to measure by 
immunochemical techniques properdin factor B in serum and other body 
fluids. The deposition of properdin factor B in body tissues or a 
corresponding depression in the amount of properdin factor B in serum 
and other body fluids is evidence of the involvement of the alternative 
to the classical pathway of activation of complement (a group of plasma 
proteins which cause the destruction of cells which are foreign to the 
body). Measurement of properdin factor B aids in the diagnosis of 
several kidney diseases, e.g., chronic glomerulonephritis (inflammation 
of the glomeruli of the kidney), lupus nephritis (kidney disease 
associated with a multisystem autoimmune disease, systemic lupus 
erythematosus), as well as several skin diseases, e.g., dermititis 
herpetiformis (presence of vesicles on the skin that burn and itch), and 
pemphigus vulgaris (large vesicles on the skin). Other diseases in which 
the alternate pathway of complement activation has been implicated 
include rheumatoid arthritis, sickle cell anemia, and gram-negative 
bacteremia.
    (b) Classification. Class II (performance standards).

Sec. 866.5330  Factor XIII, A, S, immunological test system.

    (a) Identification. A factor XIII, A, S, immunological test system 
is a device that consists of the reagents used to measure by 
immunochemical techniques the factor XIII (a bloodclotting factor), in 
platelets (A) or serum (S). Measurements of factor XIII, A, S, aid in 
the diagnosis and treatment of certain bleeding disorders resulting from 
a deficiency of this factor.
    (b) Classification. Class I (general controls).

Sec. 866.5340  Ferritin immunological test system.

    (a) Identification. A ferritin immunological test system is a device 
that consists of the reagents used to measure by immunochemical 
techniques the ferritin (an iron-storing protein) in serum and other 
body fluids. Measurements of ferritin aid in the diagnosis of diseases 
affecting iron metabolism, such as hemochromatosis (iron overload) and 
iron deficiency amemia.
    (b) Classification. Class II (performance standards).

Sec. 866.5350  Fibrinopeptide A immunological test system.

    (a) Identification. A fibrinopeptide A immunological test system is 
a device that consists of the reagents used to

[[Page 256]]

measure by immunochemical techniques the fibrinopeptide A (a blood-
clotting factor) in plasma and other body fluids. Measurement of 
fibrinopeptide A may aid in the diagnosis and treatment of certain 
blood-clotting disorders.
    (b) Classification. Class II (performance standards).

Sec. 866.5360  Cohn fraction IV immunological test system.

    (a) Identification. A Cohn fraction IV immunological test system is 
a device that consists of or measures that fraction of plasma proteins, 
predominantly alpha- and beta- globulins, used as a raw material for the 
production of pure alpha- or beta- globulins. Measurement of specific 
alpha- or beta- globulins aids in the diagnosis of many diseases, such 
as Wilson's disease (an inherited disease affecting the liver and 
brain), Tangier's disease (absence of alpha-1-lipoprotein), 
malnutrition, iron deficiency anemia, red blood cell disorders, and 
kidney disease.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21, 1982, as amended at 59 
FR 63007, Dec. 7, 1994]

Sec. 866.5370  Cohn fraction V immunological test system.

    (a) Identification. A Cohn fraction V immunological test system is a 
device that consists of or measures that fraction of plasma containing 
predominantly albumin (a plasma protein). This test aids in the 
diagnosis of diseases where albumin levels may be depressed, e.g., 
nephrosis (disease of the kidney), proteinuria (protein in the urine), 
gastroenteropathy (disease of the stomach and small intestine), 
rheumatoid arthritis, and viral hepatitis.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 59 FR 63007, Dec. 7, 1994]

Sec. 866.5380  Free secretory component immunological test system.

    (a) Identification. A free secretory component immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques free secretory component (normally a portion 
of the secretory IgA antibody molecule) in body fluids. Measurement of 
free secretory component (protein molecules) aids in the diagnosis or 
repetitive lung infections and other hypogammaglobulinemic conditions 
(low antibody levels).
    (b) Classification. Class II (performance standards).

Sec. 866.5400  Alpha-globulin immunological test system.

    (a) Identification. An alpha-globulin immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the alpha-globulin (a serum protein) in serum and other body 
fluids. Measurement of alpha-globulin may aid in the diagnosis of 
inflammatory lesions, infections, severe burns, and a variety of other 
conditions.
    (b) Classification. Class I (general controls).

Sec. 866.5420  Alpha-1-glycoproteins immunological test system.

    (a) Identification. An alpha-1-glycoproteins immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques alpha-1-glycoproteins (a group of plasma 
proteins found in the alpha-1 group when subjected to electrophoresis) 
in serum and other body fluids. Measurement of specific alpha-1-
glycoproteins may aid in the diagnosis of collagen (connective tissue) 
disorders, tuberculosis, infections, extensive malignancy, and diabetes.
    (b) Classification. Class I (general controls).

Sec. 866.5425  Alpha-2-glycoproteins immunological test system.

    (a) Identification. An alpha-2-glycoproteins immunolgical test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the alpha-2-glycoproteins (a group of plasma 
proteins found in the alpha-2 group when subjected to electrophoresis) 
in serum and other body fluids. Measurement of

[[Page 257]]

alpha-2-glycoproteins aids in the diagnosis of some cancers and 
genetically inherited deficiencies of these plasma proteins.
    (b) Classification. Class I (general controls).

Sec. 866.5430  Beta-2-glycoprotein I immunological test system.

    (a) Identification. A beta-2-glycoprotein I immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the beta-2-glycoprotein I (a serum protein) in 
serum and other body fluids. Measurement of beta-2-glycoprotein I aids 
in the diagnosis of an inherited deficiency of this serum protein.
    (b) Classification. Class I (general controls).


Sec. 866.5440  Beta-2-glycoprotein III immunological test system.

    (a) Identification. A beta-2-glycoprotein III immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the beta-2-glycoprotein III (a serum protein) 
in serum and other body fluids. Measurement of beta-2-glycoprotein III 
aids in the diagnosis of an inherited deficiency of this serum protein 
and a variety of other conditions.
    (b) Classification. Class I (general controls).

Sec. 866.5460  Haptoglobin immunological test system.

    (a) Identification. A haptoglobin immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the haptoglobin (a protein that binds hemoglobin, the oxygen-
carrying pigment in red blood cells) in serum. Measurement of 
haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in 
which the red blood cells rupture and release hemoglobin) related to the 
formation of hemoglobin-haptoglobin complexes and certain kidney 
diseases.
    (b) Classification. Class II (performance standards).

Sec. 866.5470  Hemoglobin immunological test system.

    (a) Indentification. A hemoglobin immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the different types of free hemoglobin (the oxygen-carrying 
pigment in red blood cells) in blood, urine, plasma, or other body 
fluids. Measurements of free hemoglobin aid in the diagnosis of various 
hematologic disorders, such as sickle cell anemia, Fanconi's anemia (a 
rare inherited disease), aplastic anemia (bone marrow does not produce 
enough blood cells), and leukemia (cancer of the blood-forming organs).
    (b) Classification. Class II (performance standards).

Sec. 866.5490  Hemopexin immunological test system.

    (a) Indentification. A hemopexin immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the hemopexin (a serum protein that binds heme, a component 
of hemoglobin) in serum. Measurement of hemopexin aids in the diagnosis 
of various hematologic disorders, such as hemolytic anemia (anemia due 
to shortened in vivo survival of mature red blood cells and inability of 
the bone marrow to compensate for their decreased life span) and sickle 
cell anemia.
    (b) Classification. Class II (performance standards).

Sec. 866.5500  Hypersensitivity pneumonitis immunological test system.

    (a) Identification. A hypersensitivity pneumonitis immunological 
test system is a device that consists of the reagents used to measure by 
immunochemical techniques the immunoglobulin antibodies in serum which 
react specifically with organic dust derived from fungal or animal 
protein sources. When these antibodies react with such dusts in the 
lung, immune complexes precipitate and trigger an inflammatory reaction 
(hypersensitivity pneumonitis). Measurement of these immunoglobulin G 
antibodies aids in the diagnosis of hypersensitivity pneumonitis and 
other allergic respiratory disorders.

[[Page 258]]

    (b) Classification. Class II (performance standards).

Sec. 866.5510  Immunoglobulins A, G, M, D, and E immunological test 
          system.

    (a) Identification. An immunoglobulins A, G, M, D, and E 
immunological test system is a device that consists of the reagents used 
to measure by immunochemical techniques the immunoglobulins A, G, M, D, 
an E (serum antibodies) in serum. Measurement of these immunoglobulins 
aids in the diagnosis of abnormal protein metabolism and the body's lack 
of ability to resist infectious agents.
    (b) Classification. Class II (performance standards).

Sec. 866.5520  Immunoglobulin G (Fab fragment specific) immunological 
          test system.

    (a) Identification. An immunoglobulin G (Fab fragment specific) 
immunological test system is a device that consists of the reagents used 
to measure by immunochemical techniques the Fab antigen-binding fragment 
resulting from breakdown of immunoglobulin G antibodies in urine, serum, 
and other body fluids. Measurement of Fab fragments of immunoglobulin G 
aids in the diagnosis of lymphoproliferative disorders, such as multiple 
myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia 
(increased immunoglobulin production by the spleen and bone marrow 
cells), and lymphoma (tumor of the lymphoid tissues).
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 61 FR 1119, Jan. 16, 1996]

Sec. 866.5530  Immunoglobulin G (Fc fragment specific) immunological 
          test system.

    (a) Identification. An immunoglobulin G (Fc fragment specific) 
immunological test system is a device that consists of the reagents used 
to measure by immunochemical techniques the Fc (carbohydrate containing) 
fragment of immunoglobulin G (resulting from breakdown of immunoglobulin 
G antibodies) in urine, serum, and other body fluids. Measurement of 
immunoglobulin G Fc fragments aids in the diagnosis of plasma cell 
antibody-forming abnormalities, e.g., gamma heavy chain disease.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 61 FR 1119, Jan. 16, 1996]

Sec. 866.5540  Immunoglobulin G (Fd fragment specific) immunological 
          test system.

    (a) Identification. An immunoglobulin G (Fd fragment specific) 
immunological test system is a device that consists of the reagents used 
to measure by immunochemical techniques the amino terminal (antigen-
binding) end (Fd fragment) of the heavy chain (a subunit) of the 
immunoglobulin antibody molecule in serum. Measurement of immunoglobulin 
G Fd fragments aids in the diagnosis of plasma antibody-forming cell 
abnormalities.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 59 FR 63007, Dec. 7, 1994]

Sec. 866.5550  Immunoglobulin (light chain specific) immunological test 
          system.

    (a) Identification. An immunoglobulin (light chain specific) 
immunological test system is a device that consists of the reagents used 
to measure by immunochemical techniques both kappa and lambda types of 
light chain portions of immunoglobulin molecules in serum, other body 
fluids, and tissues. In some disease states, an excess of light chains 
are produced by the antibody-forming cells. These free light chains, 
unassociated with gamma globulin molecules, can be found in a patient's 
body fluids and tissues. Measurement of the various amounts of the 
different types of light chains aids in the diagnosis of multiple 
myeloma (cancer of antibody-forming cells), lymphocytic neoplasms 
(cancer of lymphoid tissue), Waldenstrom's

[[Page 259]]

macroglobulinemia (increased production of large immunoglobulins), and 
connective tissue diseases such as rheumatoid arthritis or systemic 
lupus erythematosus.
    (b) Classification. Class II (performance standards).

Sec. 866.5560  Lactic dehydrogenase immunological test system.

    (a) Identification. A lactic dehydrogenase immunological test system 
is a device that consists of the reagents used to measure by 
immunochemical techniques the activity of the lactic dehydrogenase 
enzyme in serum. Increased levels of lactic dehydrogenase are found in a 
variety of conditions, including megaloblastic anemia (decrease in the 
number of mature red blood cells), myocardial infarction (heart 
disease), and some forms of leukemia (cancer of the blood-forming 
organs). However, the diagnostic usefulness of this device is limited 
because of the many conditions known to cause increased lactic 
dehydrogenase levels.
    (b) Classification. Class I (general controls).

Sec. 866.5570  Lactoferrin immunological test system.

    (a) Identification. A lactoferrin immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the lactoferrin (an iron-binding protein with the ability to 
inhibit the growth of bacteria) in serum, breast milk, other body 
fluids, and tissues. Measurement of lactoferrin may aid in the diagnosis 
of an inherited deficiency of this protein.
    (b) Classification. Class I (general controls).

Sec. 866.5580  Alpha-1-lipoprotein immunological test system.

    (a) Identification. An alpha-1-lipoprotein immunological test system 
is a device that consists of the reagents used to measure by 
immunochemical techniques the alpha-1-lipoprotein (high-density 
lipoprotein) in serum and plasma. Measurement of alpha-1-lipoprotein may 
aid in the diagnosis of Tangier disease (a hereditary disorder of fat 
metabolism).
    (b) Classification. Class II (performance standards).

Sec. 866.5590  Lipoprotein X immunological test system.

    (a) Identification. A lipoprotein X immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques lipoprotein X (a high-density lipoprotein) in serum and other 
body fluids. Measurement of lipoprotein X aids in the diagnosis of 
obstructive liver disease.
    (b) Classification. Class I (general controls).

Sec. 866.5600  Low-density lipoprotein immunological test system.

    (a) Identification. A low-density lipoprotein immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the low-density lipoprotein in serum and other 
body fluids. Measurement of low-density lipoprotein in serum may aid in 
the diagnosis of disorders of lipid (fat) metabolism and help to 
identify young persons at risk from cardiovascular diseases.
    (b) Classification. Class II (performance standards).

Sec. 866.5620  Alpha-2-macroglobulin immunological test system.

    (a) Identification. An alpha-2-macroglobulin immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the alpha-2-macroglobulin (a serum protein) in 
plasma. Measurement of alpha-2-macroglobulin may aid in the diagnosis of 
blood-clotting or clot lysis disorders.
    (b) Classification. Class II (performance standards).

Sec. 866.5630  Beta-2-microglobulin immunological test system.

    (a) Identification. A beta-2-microglobulin immunological test system 
is a device that consists of the reagents used to measure by 
immunochemical techniques beta-2-microglobulin (a protein molecule) in 
serum, urine, and other body fluids. Measurement of beta-2-microglobulin 
aids in the diagnosis of active rheumatoid arthritis and kidney disease.

[[Page 260]]

    (b) Classification. Class II (performance standards).

Sec. 866.5640  Infectious mononucleosis immunological test system.

    (a) Identification. An infectious mononucleosis immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques heterophile antibodies frequently associated 
with infectious mononucleosis in serum, plasma, and other body fluids. 
Measurements of these antibodies aid in the diagnosis of infectious 
mononucleosis.
    (b) Classification. Class II (performance standards).
[47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21, 1982]

Sec. 866.5660  Multiple autoantibodies immunological test system.

    (a) Identification. A multiple autoantibodies immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the autoantibodies (antibodies produced 
against the body's own tissues) in serum and other body fluids. 
Measurement of multiple autoantibodies aids in the diagnosis of 
autoimmune disorders (disease produced when the body's own tissues are 
injured by autoantibodies).
    (b) Classification. Class II (performance standards).

Sec. 866.5680  Myoglobin immunological test system.

    (a) Identification. A myoglobin immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the myoglobin (an oxygen storage protein found in muscle) in 
serum and other body fluids. Measurement of myoglobin aids in the rapid 
diagnosis of heart or renal disease.
    (b) Classification. Class II (performance standards).

Sec. 866.5700  Whole human plasma or serum immunological test system.

    (a) Identification. A whole human plasma or serum immunological test 
system is a device that consists of reagents used to measure by 
immunochemical techniques the proteins in plasma or serum. Measurements 
of proteins in plasma or serum aid in the diagnosis of any disease 
concerned with abnormal levels of plasma or serum proteins, e.g., 
agammaglobulinemia, allergies, multiple myeloma, rheumatoid vasculitis, 
or hereditary angioneurotic edema.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 59 FR 63007, Dec. 7, 1994]

Sec. 866.5715  Plasminogen immunological test system.

    (a) Identification. A plasminogen immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the plasminogen (an inactive substance from which plasmin, a 
blood-clotting factor, is formed) in serum, other body fluids, and 
tissues. Measurement of plasminogen levels may aid in the diagnosis of 
fibrinolytic (blood-clotting) disorders.
    (b) Classification. Class I (general controls).

Sec. 866.5735  Prothrombin immunological test system.

    (a) Identification. A prothrombin immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the prothrombin (clotting factor II) in serum. Measurements 
of the amount of antigenically competent (ability to react with protein 
antibodies) prothrombin aid in the diagnosis of blood-clotting 
disorders.
    (b) Classification. Class I (general controls).

Sec. 866.5750  Radioallergosorbent (RAST) immunological test system.

    (a) Identification. A radioallergosorbent immunological test system 
is a device that consists of the reagents used to measure by 
immunochemical techniques the allergen antibodies (antibodies which 
cause an allergic reaction) specific for a given allergen. Measurement 
of specific allergen antibodies may aid in the diagnosis of asthma, 
allergies, and other pulmonary disorders.

[[Page 261]]

    (b) Classification. Class II (performance standards).

Sec. 866.5765  Retinol-binding protein immunological test system.

    (a) Identification. A retinol-binding protein immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the retinol-binding protein that binds and 
transports vitamin A in serum and urine. Measurement of this protein may 
aid in the diagnosis of kidney disease and in monitoring patients with 
kidney transplants.
    (b) Classification. Class I (general controls).

Sec. 866.5775  Rheumatoid factor immunological test system.

    (a) Identification. A rheumatoid factor immunological test system is 
a device that consists of the reagents used to measure by immunochemical 
techniques the rheumatoid factor (antibodies to immunoglobulins) in 
serum, other body fluids, and tissues. Measurement of rheumatoid factor 
may aid in the diagnosis of rheumatoid arthritis.
    (b) Classification. Class II (performance standards).

Sec. 866.5800  Seminal fluid (sperm) immunological test system.

    (a) Identification. A seminal fluid (sperm) immunological test 
system is a device that consists of the reagents used for legal purposes 
to identify and differentiate animal and human semen. The test results 
may be used as court evidence in alleged instances of rape and other 
sex-related crimes.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[54 FR 25047, June 12, 1989]

Sec. 866.5820  Systemic lupus erythematosus immunological test system.

    (a) Identification. A systemic lupus erythematosus (SLE) 
immunological test system is a device that consists of the reagents used 
to measure by immunochemical techniques the autoimmune antibodies in 
serum and other body fluids that react with cellular nuclear double-
stranded deoxyribonucleic acid (DNA) or other nuclear constituents that 
are specifically diagnostic of SLE. Measurement of nuclear double-
stranded DNA antibodies aids in the diagnosis of SLE (a multisystem 
autoimmune disease in which tissues are attacked by the person's own 
antibodies).
    (b) Classification. Class II (performance standards).

Sec. 866.5860  Total spinal fluid immunological test system.

    (a) Identification. A total spinal fluid immunological test system 
is a device that consists of the reagents used to measure by 
immunochemical techniques the total protein in cerebrospinal fluid. 
Measurement of spinal fluid proteins may aid in the diagnosis of 
multiple sclerosis and other diseases of the nervous system.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 61 FR 1119, Jan. 16, 1996]

Sec. 866.5870  Thyroid autoantibody immunological test system.

    (a) Identification. A thyroid autoantibody immunological test system 
is a device that consists of the reagents used to measure by 
immunochemical techniques the thyroid autoantibodies (antibodies 
produced against the body's own tissues). Measurement of thyroid 
autoantibodies may aid in the diagnosis of certain thyroid disorders, 
such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic 
goiter (enlargement of thyroid gland), Grave's disease (enlargement of 
the thyroid gland with protrusion of the eyeballs), and cancer of the 
thyroid.
    (b) Classification. Class II (performance standards).

Sec. 866.5880  Transferrin immunological test system.

    (a) Identification. A transferrin immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the transferrin (an iron-binding and transporting serum 
protein) in serum, plasma, and other body fluids.

[[Page 262]]

Measurement of transferrin levels aids in the diagnosis of malnutrition, 
acute inflammation, infection, and red blood cell disorders, such as 
iron deficiency anemia.
    (b) Classification. Class II (performance standards).

Sec. 866.5890  Inter-alpha trypsin inhibitor immunological test system.

    (a) Identification. An inter-alpha trypsin inhibitor immunological 
test system is a device that consists of the reagents used to measure by 
immunochemical techniques the inter-alpha trypsin inhibitor (a protein) 
in serum and other body fluids. Measurement of inter-alpha trypsin 
inhibitor may aid in the diagnosis of acute bacterial infection and 
inflammation.
    (b) Classification. Class I (general controls).
[47 FR 50823, Nov. 9, 1982, as amended at 53 FR 11253, Apr. 6, 1988]

     Subpart G--Tumor Associated Antigen immunological Test Systems

Sec. 866.6010  Tumor-associated antigen immunological test system.

    (a) Identification. A tumor-associated antigen immunological test 
system is a device that consists of reagents used to qualitatively or 
quantitatively measure, by immunochemical techniques, tumor-associated 
antigens in serum, plasma, urine, or other body fluids. This device is 
intended as an aid in monitoring patients for disease progress or 
response to therapy or for the detection of recurrent or residual 
disease.
    (b) Classification. Class II (special controls). Tumor markers must 
comply with the following special controls: (1) A guidance document 
entitled ``Guidance Document for the Submission of Tumor Associated 
Antigen Premarket Notifications (510(k)s) to FDA,'' and (2) voluntary 
assay performance standards issued by the National Committee on Clinical 
Laboratory Standards.
[62 FR 66005, Dec. 17, 1997]

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