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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 030 Date of Recognition 01/15/2013 
FR Recognition Number 7-238
Standard
CLSI MM06-A2 (Replaces MM06-A)
Quantitative Molecular Methods for Infectious Diseeases; Approved Guideline - Second Edition
Scope/Abstract
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
Unclassified Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus Class 3 MZP
Unclassified Cytomegalovirus (Cmv) Dna Quantitative Assay Class 3 PAB
Unclassified Hepatitis Viral B Dna Detection Class 3 MKT
Unclassified Monitor,Test,Hiv-1 Class 3 MTL
Unclassified Test, Hiv Detection Class 3 MZF
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contacts
 Haja Sittana El Mubarak
  FDA/OMPT/CDRH/OIR/DMD/VIR2/
  301-796-6193
  hajasittana.elmubarak@fda.hhs.gov
 Li Li
  FDA/OMPT/CDRH/OIR/DMD/VIR1/
  301-796-6200
  li.li2@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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