Recognized Consensus Standards

Recognition List Number: 028 Publication Date: 03/16/2012 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 7-222: CLSI / NCCLS M24-A2, Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes; Approved Standards - Second Edition. (InVitro Diagnostics)

Date of Standard: 2011. 

Addresses of Standards Organizations:

  Clinical Laboratory Standards Institute (CLSI)

  950 West Valley Road

  Suite 2500

  Wayne, PA 19087

  National Committee for Clinical Laboratory Standards (NCCLS)

  950 West Valley Road

  Suite 2500

  Wayne, PA 19087

CDRH Office and Division Associated with Recognized Standards:

OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)

Devices Affected:

Antimicrobial susceptibility systems regulated under 21 CFR 866.1620, 21 CFR 866.1640, and 21 CFR 866.1700

Processes Affected:

510(k), IDE, PDP

Type of Standard:

 National

Extent of Recognition:

Partial: CDRH recognizes the methodology as this standard provides protocols and related quality control parameters for the susceptibility testing of Mycobacteria, Nocardiae spp and other aerobic actinomycetes but not interpretive criteria.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§866.1620	Susceptibility Test Discs, Antimicrobial	Class 2	JTN
Regulation Number	Device Name	Device Class	Product Code
§866.1640	Susceptibility Test Powders, Antimycobacterial	Class 2	MJA
Regulation Number	Device Name	Device Class	Product Code
§866.1700	Culture Media, Antimycobacteria, Susceptibility Test	Class 2	MJD

Relevant Guidance:

1. Review Criteria for Assessment of Antimicrobial Susceptibility Discs
2. Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA

FDA Technical Contact:

  Yvonne Shea

  FDA/CDRH/OIVD

  10903 New Hampshire Avenue Building 66, Room 5510

  Silver Spring MD 20993

  301/796-0576

  Email: yvonne.shea@fda.hhs.gov