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Recognized Consensus Standards

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Recognition List Number: 013 FR Publication 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 Development Organization:
 Clinical Laboratory Standards Institute (CLSI)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
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:
 Horizontal, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
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
§866.5520 Fab, Antigen, Antiserum, Control Class 1 DCE
§866.5520 Igg (Fab Fragment Specific), Antigen, Antiserum, Control Class 1 DFK
§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
§866.5540 Igg (Fd Fragment Specific), Antigen, Antiserum, Control Class 1 DAQ
§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:
 Sic Chan
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5627
  Silver Spring MD 20993
  301/796-7015
  email: sic.chan@fda.hhs.gov
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