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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 7-222: CLSI M24-A2, susceptibility testing of mycobacteria, nocardiae and other aerobic actinomycetes; approved standards - second edition. (InVitro Diagnostics)

Date of Standard: 2011. 
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 IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
Antimicrobial susceptibility systems regulated under 21 CFR 866.1620, 21 CFR 866.1640, and 21 CFR 866.1700
Processes Affected:
510(k), PDP, Pre-submission
Type of Standard:
 National, Horizontal
Extent of Recognition:
Complete standard, with the exception of the interpretive criteria and quality control parameters when different from that in FDA approved drug labels. In the absence of the interpretive criteria and quality control parameters in FDA approved drug labels, consult the technical contacts.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§866.1620 Susceptibility Test Discs, Antimicrobial Class 2 JTN
§866.1640 Susceptibility Test Powders, Antimycobacterial Class 2 MJA
§866.1700 Culture Media, Antimycobacteria, Susceptibility Test Class 2 MJD
Relevant Guidance:
Review Criteria for Assessment of Antimicrobial Susceptibility Discs

Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA
FDA Technical Contacts:
 Patricia Conville
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5510
  Silver Spring MD 20993
  301/796-6942
  email: patricia.conville@fda.hhs.gov
 Janice Washington
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5554
  Silver Spring MD 20993
  301/796-6207
  email: janice.washington@fda.hhs.gov
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