Recognized Consensus Standards

Recognition List Number: 029 Publication Date: 08/20/2012 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 7-231: CLSI M100-S22, Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Second Informational Supplement. (InVitro Diagnostics)

Date of Standard: 2012. 

Address of Standards 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)
	DIVISION OF MICROBIOLOGY (DMD)

(2) OFFICE OF COMPLIANCE (OC)

Devices Affected:

Antimicrobial Susceptibility Test Powder Regulated under 21 CFR 866.1640; Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Systems under 21 CFR 866.1645

Processes Affected:

510(k), Pre-IDE

Type of Standard:

 Horizontal, National

Extent of Recognition:

Partial Recognition; all procedures and methods are recognized, interpretive criteria and QC parameters, when different from CDER approved drug labeling, not recognized.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§866.1640	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Class 2	LRG
§866.1640	Manual Antimicrobial Susceptibility Test Systems	Class 2	JWY
§866.1640	Panels, Test, Susceptibility, Antimicrobial	Class 2	LTT
§866.1640	Susceptibility Test Cards, Antimicrobial	Class 2	LTW
Regulation Number	Device Name	Device Class	Product Code
§866.1645	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Class 2	LON

Relevant Guidance:

Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems

FDA Technical Contact:

  Alexandra Wong

  FDA/CDRH/OIVD

  10993 New Hampshire Avenue Building 66, Room 5502

  Silver Spring MD 20993

  301/796-6210

  Email: alexandra.wong@fda.hhs.gov