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Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators |
Document issued on: February 22, 1999
This document replaces In Vitro Diagnostic Calibrators, July 20, 1998
U.S. Department Of Health And Human Services Food and Drug Administration Center for Devices and Radiological Health Chemistry, Toxicology, and Hematology
Branch |
Comments and suggestions may be submitted at any time for Agency consideration to, Division of Clinical Laboratory Devices, HFZ-440, Office of Device Evaluation, 9200 Corporate Blvd., Rockville, MD, 20850. Comments may not be acted upon by the Agency until the document is next revised or updated. For questions regarding the use or interpretation of this guidance, contact Dr. Joseph Hackett at 301-594-3084 or by electronic mail, at JLH@cdrh.fda.gov.
World Wide Web/CDRH home page: http://www.fda.gov/cdrh, or CDRH Facts on Demand at 1-800-899-0381 or 1-301-827-0111, specify number 1247 when prompted for the document shelf number.
The suggested content of abbreviated 510(k) submissions is identified in guidance prepared by the Center for Devices and Radiological Health on March 20, 1998, titled, "The New 510(k) Paradigm; Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notification." The guidance document is available on theWorld Wide Web/CDRH home page: http://www.fda.gov/cdrh, or CDRH Facts on Demand at 1-800-899-0381 or 1-301-827-0111.
Abbreviated 510(k) submissions for In Vitro Diagnostic Calibrators should include the following:
Device: In Vitro Diagnostic Calibrators
Common Name(s): Calibrator
Class: II
Classification Panels: | Clinical Chemistry (75), Hematology (81), Immunology (82), Microbiology (83), or Toxicology (91) |
Product Codes: | JIX, | Calibrator, Multi-Analyte Mixture |
JIS, | Calibrator, Primary | |
JIT, | Calibrator, Secondary | |
JTW, | Calibrator, Surrogate | |
DKB, | Calibrators, Drug Mixture | |
DLJ, | Calibrators, Drug Specific | |
DNN, | Calibrators, Ethyl Alcohol | |
KRX, | Calibrator for Cell Indices | |
KRZ, | Calibrator for Hemoglobin and Hematocrit Measurement | |
KRY, | Calibrator for Platelet Counting | |
KSA, | Calibrator for Red-Cell and White-Cell Counting | |
GJZ, | Cyanomethemoglobin Reagent and Standard Solution | |
Fibrinogen Standard |
Regulation numbers: | 21 CFR 862.1150, 21 CFR 862.3200, 21 CFR 864.8150, 21 CFR 864. 8165, 21 CFR 864.7340, 21 CFR 864.7500, 21 CFR 864.8175, 21 CFR 864.8185 |
IVD device calibration is most commonly performed using calibrators (reference materials) specifically intended to be used as a standard curve or cut-off point for an assay.
A calibrator has an assigned value that is established by the manufacturer by a reference method. Calibrators exist in a variety of matrices such as simulated aqueous, serum, plasma or other types of specimens.
Primary reference calibrators are highly purified chemicals that can be directly weighed or measured to produce a solution of known concentration. Alternatively, they may be more complex biological materials having received a value assignment using reference (standard) methodology. They are supplied with a certificate of analysis for each lot (For example, standard reference materials (SRMs) from the U.S. National Institute of Standards and Technology (NIST)).
Secondary reference materials are those materials or solutions with which the test sample is compared in order to determine the concentration of analytes or other substances. The value of secondary reference materials is usually determined by the manufacturer by an analysis of an aliquot of the solution by an acceptable reference method, using a primary reference material to calibrate the IVD device technology. This guidance deals with the secondary calibrators which play a key role in the performance characteristics of the IVD device technology method, particularly the accuracy, stability, reproducibility, and linearity.
Suggested indications for use statement
Include proposed labeling that conforms with 21 CFR 809.10 and reflects the performance data described in the "summary report".
Other: For a multi-purpose instrument used for diagnostic purposes, refer to 21 CFR 809.10(b) (1), (2), (6), (14) and (15).
The labeling must meet the requirements of 21 CFR 809.10. It is recommended that the labeling (package insert) for In Vitro Diagnostic products include intended use and type of procedure (qualitative or quantitative); summary and explanation of test (including literature references, special merits, limitations, deviations from original methods and its effects on results); and test principle (chemical, biological, microbiological, or immunological reactions and techniques).
Note: | The assigned values should be clinically relevant and should be set at or near the medical decision levels for the analyte. For qualitative tests, it is recommended that positive and negative cut-offs be carefully identified and that the calibrators be designed to be near these cut-offs. |
Checklist and reference to page in 510(k):
Uploaded on March 29, 1999
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