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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 020 FR Publication Date: 09/09/2008 

Part B: Supplementary Information

Recognition Number 7-132: CLSI MM03-A2, molecular diagnostic methods for infectious diseases; approved guideline. (InVitro Diagnostics)

Date of Standard: 2006. 
Address of Standards Development Organization:
 Clinical Laboratory Standards Institute (CLSI)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
IVDs to Detect Infectious Diseases by Molecular Diagnostic Methodology
Processes Affected:
Manufacturing/Devices Evaluation (510(k), PMA, PDP, IDE)
Type of Standard:
 National, Horizontal
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§866.3120 Dna Probe, Nucleic Acid Amplification, Chlamydia Class 1 MKZ
§866.3120 Dna-Reagents, Chlamydia Class 1 LSK
§866.3370 Dna-Reagents, Mycobacterium Spp. Class 1 LQF
§866.3390 Dna-Reagents, Neisseria Class 2 LSL
Relevant Guidance:
Review Criteria for Nucleic Acid Amplification Based In Vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms

Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Mycobacterium species [tuberculosis]

Attachments to the Mycobacterium Guidance Document
FDA Technical Contact:
 Pushya Potnis
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 64, Room 3022
  Silver Spring MD 20993
  301/796-5221
  email: pushya.potnis@fda.hhs.gov
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