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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 021 Date of Entry 03/18/2009 
FR Recognition Number 7-176
Standard
CLSI  I/LA30-A (Replaces I/LA30-P)
Immunoassay Interference by Endogenous Antibodies; Approved Guideline.
Scope/Abstract
This standard presents information on the origin, nature, and prevalence of circulating endogenous antibodies, which cause interference with immunoassay results. The mechanisms of the interference along with some specific examples are included. To address the problem, recommendations for regulatory bodies, reagent manufacturers, and laboratorians are provided.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
All assays that utilize immunoassay methods/reagents
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
 Yung Chan
  FDA/OC/CDRH/OPEQ/OIDRH/DCTD/
  301-796-6138
  yung.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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