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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 7-180
Standard
CLSI  M34-A (Replaces M24-P)
Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline.
Scope/Abstract
This document addresses technical and interpretive considerations for use of Western blot assays that detect antibodies to Borrelia burgdorferi and other Borrelia species that cause Lyme Disease.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§866.3830 Reagent, Borrelia Serological Reagent Class 2 LSR
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
 Maria Esteve-Gasent
  FDA/OC/CDRH/OPEQ/OHTVII/DMD/VIR2/
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  maria.esteve-gasent@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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