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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 030 Date of Entry 01/15/2013 
FR Recognition Number 7-238
CLSI  MM06-A2 (Replaces MM06-A)
Quantitative Molecular Methods for Infectious Diseases; Approved Guideline - Second Edition
This document provides guidance for the development and use of quantitative molecular methods, such as nucleic acid probes and nucleic acid amplification techniques of the target sequences specific to particular microorganisms, and presents recommendations for quality assurance, proficiency testing, and interpretation of results.

Issues specific to the quantification of nucleic acid in diagnostic testing and monitoring, particularly in viral diseases, include an update on technologies used in molecular quantification; specimen handling and preparation; standards, calibrators, and reference materials; analytical and clinical verification/validation; reporting and interpreting results; clinical utility; and recommendations for manufacturers and clinical laboratories.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§866.3170 Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus Class 2 MZP
§866.3956 Test, Hiv Detection Class 2 MZF
N/A Hepatitis Viral B Dna Detection Class 3 MKT
N/A Monitor,Test,Hiv-1 Class 3 MTL
N/A Cytomegalovirus (Cmv) Dna Quantitative Assay Class 3 PAB
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
 Li Li
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.