Recognized Consensus Standards

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

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 7-197: CLSI M35-A2, Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second 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 Offices and Divisions Associated with Recognized Standards:

(1) OFFICE OF DEVICE EVALUATION (ODE)

(2) OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)

(3) OFFICE OF COMPLIANCE (OC)

Devices Affected:

Microorganism differentiation and identification device regulated under 21 CFR 866.2660

Processes Affected:

510(k), pre-IDE

Type of Standard:

 Vertical, National

Extent of Recognition:

Complete standard

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§866.3310	Hepatitis A Test (Antibody And Igm Antibody)	Class 2	LOL
Regulation Number	Device Name	Device Class	Product Code
§866.2660	Discs, Strips And Reagents, Microorganism Differentiation	Class 1	JTO
§866.2660	Gram Negative Identification Panel	Class 1	LQM
§866.2660	Instrument For Auto Reader Of Overnight Microorganism Identification System	Class 1	LRH
§866.2660	Kit, Anaerobic Identification	Class 1	JSP
§866.2660	Kit, Screening, Yeast	Class 1	JXC

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 Contacts:

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

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