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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 051 Date of Entry 01/14/2019 
FR Recognition Number 7-285
Standard
CLSI  M48-A 2nd Edition
Laboratory Detection and Identification of Mycobacteria
Scope/Abstract
This standard addresses topics related to the laboratory diagnosis of mycobacterial infections including safety and related issues, levels of service and referrals, clinical significance of mycobacteria, acceptable specimen types and their collection, transport and storage, specimen processing methods, methods for the direct detection of mycobacteria in clinical specimens, culture methods including contamination issues, reporting and quality control, and phenotypic and genotypic identification procedures.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§866.2660 Kit, Identification, Mycobacteria Class 1 JSY
§866.3370 Antiserum, Fluorescent, Mycobacterium Tuberculosis Class 1 GRT
§866.3370 Dna-Reagents, Mycobacterium Spp. Class 1 LQF
§866.3370 Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis Class 1 NDZ
§866.3370 System, Mycolic Acid Analysis, Mycobacterium Tuberculosis Class 1 NJO
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
 Carolina Sempertegui-Sosa
  CDRH/OPEQ/OHTVII/DMD/BAC2
  --
  carolina.sempertegui-sosa@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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