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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 013 Date of Entry 11/08/2005 
FR Recognition Number 7-113
Standard
CLSI  I/LA23-A (Replaces I/LA23-P)
Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline
Scope/Abstract
This guideline addresses components for harmonizing and assessing the quality of immunoassay systems for several commonly used dose-response indicator categories, e.g., radioisotopes, enzymes, fluorescence, luminescence, reagents, and experimental components criteria essential to characterizing an immunoassay.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§866.5510 Radioimmunoassay, Immunoglobulins (G, A, M) Class 2 CFQ
§866.5510 Igd, Antigen, Antiserum, Control Class 2 CZJ
§866.5510 Iga, Peroxidase, Antigen, Antiserum, Control Class 2 CZL
§866.5510 Iga, Antigen, Antiserum, Control Class 2 CZP
§866.5510 Igg, Peroxidase, Antigen, Antiserum, Control Class 2 DAA
§866.5510 Igg, Antigen, Antiserum, Control Class 2 DEW
§866.5510 Igg (Gamma Chain Specific), Antigen, Antiserum, Control Class 2 DFZ
§866.5510 Igd, Peroxidase, Antigen, Antiserum, Control Class 2 DGH
§866.5510 Ige, Peroxidase, Antigen, Antiserum, Control Class 2 DGO
§866.5510 Radioimmunoassay, Immunoglobulins (D, E) Class 2 JHR
§866.5520 Fab, Antigen, Antiserum, Control Class 1 DCE
§866.5520 Igg (Fab Fragment Specific), Antigen, Antiserum, Control Class 1 DFK
§866.5530 Igg (Fc Fragment Specific), Antigen, Antiserum, Control Class 1 DAS
§866.5530 Fc, Antigen, Antiserum, Control Class 1 DBN
§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 Lambda, Antigen, Antiserum, Control Class 2 DEH
§866.5550 Lambda, Peroxidase, Antigen, Antiserum, Control Class 2 DEP
§866.5550 Igm, Peroxidase, Antigen, Antiserum, Control Class 2 DEY
§866.5550 Kappa, Peroxidase, Antigen, Antiserum, Control Class 2 DFD
§866.5550 Kappa, Antigen, Antiserum, Control Class 2 DFH
§866.5550 Igm, Antigen, Antiserum, Control Class 2 DFT
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Sic Chan
  FDA/OC/CDRH/OPEQ/OIDRH/DIHD/IMFB/
  301-796-7015
  sic.chan@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
*These are provided as examples and others may be applicable.
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