Recognized Consensus Standards

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

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 7-200: CLSI M48-A, Laboratory Detection and Identification of Mycobacteria; Approved Guideline. (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:

Mycobacterium tuberculosis immunofluorescent reagents regulated under 21 CFR 866.3370 and Microorganism differentiation and identification device under 21 CFR 866.2600

Processes Affected:

510(k), pre-IDE

Type of Standard:

Vertical, National

Extent of Recognition:

Partial recognition; Methodology accepted but not interpretive criteria when it differs from those in CDER approved drug package inserts

Related CFR Citations and Product Codes:


Regulation Number	Device Name	Device Class	Product Code
§866.2660	Kit, Identification, Mycobacteria	Class 1	JSY

Regulation Number	Device Name	Device Class	Product Code
§866.3370	Antiserum, Fluorescent, Mycobacterium Tuberculosis	Class 1	GRT
§866.3370	Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis	Class 1	NDZ
§866.3370	Dna-Reagents, Mycobacterium Spp.	Class 1	LQF
§866.3370	System, Mycolic Acid Analysis, Mycobacterium Tuberculosis	Class 1	NJO