Recognized Consensus Standards

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

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 7-218: CLSI M45-A2, Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline - Second Edition. (InVitro Diagnostics)

Date of Standard: 2006. 

Address of Standards Organization:

  Clinical Laboratory Standards Institute (CLSI)

  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)
	DIVISION OF MICROBIOLOGY (DMD)

Devices Affected:

Antimicrobial Susceptibility minimum inhibitory concentration (MIC) and disk diffusion devices.

Processes Affected:

510(k), Pre-IDE

Type of Standard:

 Horizontal, National

Extent of Recognition:

Partial: CDRH recognizes the methods used for MIC and disk diffusion test, however we can not recognize interpretive criteria when different from that in CDER approved drug labels.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§866.1620	Discs, Elution	Class 2	LTX
§866.1620	Susceptibility Test Discs, Antimicrobial	Class 2	JTN
Regulation Number	Device Name	Device Class	Product Code
§866.1640	Manual Antimicrobial Susceptibility Test Systems	Class 2	JWY
§866.1640	Panels, Test, Susceptibility, Antimicrobial	Class 2	LTT
§866.1640	Solution, Antimicrobial	Class 2	LOP
§866.1640	Susceptibility Test Cards, Antimicrobial	Class 2	LTW
§866.1640	Susceptibility Test Powders, Antimicrobial	Class 2	JTT
§866.1640	Susceptibility Test Powders, Antimycobacterial	Class 2	MJA
Regulation Number	Device Name	Device Class	Product Code
§866.1645	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Class 2	LON
Regulation Number	Device Name	Device Class	Product Code
§866.1700	Culture Media, Antifungal, Susceptibility Test	Class 2	MJE
§866.1700	Culture Media, Antimicrobial Susceptibility Test	Class 2	LKA
§866.1700	Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar	Class 2	JSO
§866.1700	Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth	Class 2	JTZ
§866.1700	Culture Media, Antimycobacteria, Susceptibility Test	Class 2	MJD

Relevant Guidance:

There is no relevant guidance developed at this time.

FDA Technical Contacts:

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

Ribhi Shawar, Ph.D.   FDA/CDRH/OIVD   10903 New Hampshire Avenue Building 66, Room 5513   Silver Spring MD 20993   301/796-6698   Email: ribhi.shawar@fda.hhs.gov