Recognized Consensus Standards

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

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 7-198: CLSI M23-A3, Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters; Approved Guideline - Third Edition. (InVitro Diagnostics)

Date of Standard: 2008. 

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:

IVDS

Processes Affected:

510(K), PMA, IDE, PDP

Type of Standard:

 National, Horizontal

Extent of Recognition:

Complete standard

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§866.1620	Discs, Elution	Class 2	LTX
§866.1620	Susceptibility Test Discs, Antimicrobial	Class 2	JTN
§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
§866.1640	Susceptibility Test Powders, Antimicrobial	Class 2	JTT
Regulation Number	Device Name	Device Class	Product Code
§866.1640	Susceptibility Test Powders, Antimicrobial	Class 2	JTT
§866.1640	Manual Antimicrobial Susceptibility Test Systems	Class 2	JWY
§866.1640	Reagent/Device, Inoculum Calibration	Class 2	LIE
§866.1640	Solution, Antimicrobial	Class 2	LOP
§866.1640	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Class 2	LRG
§866.1640	Panels, Test, Susceptibility, Antimicrobial	Class 2	LTT
§866.1640	Susceptibility Test Cards, Antimicrobial	Class 2	LTW
§866.1640	Susceptibility Test Powders, Antimycobacterial	Class 2	MJA
§866.1640	System,Test,Genotypic Detection,Resistant Markers,Staphylococcus Colonies	Class 2	MYI
§866.1640	Susceptibility Test Plate, Antifungal	Class 2	NGZ
§866.1640	System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species	Class 2	NIJ
§866.1640	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen	Class 2	NQX
Regulation Number	Device Name	Device Class	Product Code
§866.1645	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Class 2	LON

Relevant Guidance:

There is no relevant guidance developed at this time.

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