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Recognized Consensus Standards

Recognition List Number: 013  Effective Date: 10/31/2005 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 7-113: CLSI I/LA23-A, Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guidelines. (InVitro Diagnostics)

Date of Standard: 2004. 
Address of Standards Organization:
  CLINICAL LABORATORY STANDARDS INSTITUTE (CLSI)
  940 WEST VALLEY ROAD
  SUITE 1400
  WAYNE, PA 19087
 
CDRH Offices and Divisions Associated with Recognized Standards:
(1)OFFICE OF IN VITRO DIAGNOSTIC DEVICE EVALUATION AND SAFETY (OIVD)
DIVISION OF IMMUNOLOGY AND HEMATOLOGY DEVICES (DIHD)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
Immunoglobulins A, G, M, D, and E, immunological test system devices using radioimmunoassay methods or enzyme, fluorescence, or luminescence immunoassay methods
Processes Affected:
510(k), PMA, PDP, IDE
Type of Standard:
  National, Horizontal
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
 
CFR §866.5510
Regulation
Number		 Device Name Device
Class		 Product
Code
§866.5510 Iga, Antigen, Antiserum, Control Class 2 CZP
§866.5510 Iga, Peroxidase, Antigen, Antiserum, Control Class 2 CZL
§866.5510 Igd, Antigen, Antiserum, Control Class 2 CZJ
§866.5510 Igd, Peroxidase, Antigen, Antiserum, Control Class 2 DGH
§866.5510 Ige, Peroxidase, Antigen, Antiserum, Control Class 2 DGO
§866.5510 Igg (Gamma Chain Specific), Antigen, Antiserum, Control Class 2 DFZ
§866.5510 Igg, Antigen, Antiserum, Control Class 2 DEW
§866.5510 Igg, Peroxidase, Antigen, Antiserum, Control Class 2 DAA
§866.5510 Radioimmunoassay, Immunoglobulins (D, E) Class 2 JHR
§866.5510 Radioimmunoassay, Immunoglobulins (G, A, M) Class 2 CFQ
 
CFR §866.5520
Regulation
Number		 Device Name Device
Class		 Product
Code
§866.5520 Fab, Antigen, Antiserum, Control Class 1 DCE
§866.5520 Igg (Fab Fragment Specific), Antigen, Antiserum, Control Class 1 DFK
 
CFR §866.5530
Regulation
Number		 Device Name Device
Class		 Product
Code
§866.5530 Fc, Antigen, Antiserum, Control Class 1 DBN
§866.5530 Igg (Fc Fragment Specific), Antigen, Antiserum, Control Class 1 DAS
§866.5530 Reagent, Immunoassay, Igg Class 1 KTO
 
CFR §866.5540
Regulation
Number		 Device Name Device
Class		 Product
Code
§866.5540 Igg (Fd Fragment Specific), Antigen, Antiserum, Control Class 1 DAQ
 
CFR §866.5550
Regulation
Number		 Device Name Device
Class		 Product
Code
§866.5550 Igm (Mu Chain Specific), Antigen, Antiserum, Control Class 2 DAO
§866.5550 Igm, Antigen, Antiserum, Control Class 2 DFT
§866.5550 Igm, Peroxidase, Antigen, Antiserum, Control Class 2 DEY
§866.5550 Kappa, Antigen, Antiserum, Control Class 2 DFH
§866.5550 Kappa, Peroxidase, Antigen, Antiserum, Control Class 2 DFD
§866.5550 Lambda, Antigen, Antiserum, Control Class 2 DEH
§866.5550 Lambda, Peroxidase, Antigen, Antiserum, Control Class 2 DEP
 
FDA Technical Contact:
  James Reeves
  FDA/CDRH/OIVD
  2098 GAITHER ROAD, HFZ-440
  ROCKVILLE MD 20850
  240/276-1290
  Email: james.reeves@fda.hhs.gov

Database Updated 09/17/2008

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