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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 013 Date of Recognition 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
§866.5550 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
§866.5540 Igg (Fd Fragment Specific), Antigen, Antiserum, Control Class 1 DAQ
§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
§866.5520 Fab, Antigen, Antiserum, Control Class 1 DCE
§866.5520 Igg (Fab Fragment Specific), Antigen, Antiserum, Control Class 1 DFK
§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
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Sic Chan
  FDA/OMPT/CDRH/OIR/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
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