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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

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 Development 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-submission
Type of Standard:
 National, Horizontal
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§866.2660 Kit, Identification, Mycobacteria Class 1 JSY
§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
Relevant Guidance:
1. Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Mycobacterium Spp. [Tuberculosis(TB)]
FDA Technical Contacts:
 Janice Washington
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5554
  Silver Spring MD 20993
  301/796-6207
  email: janice.washington@fda.hhs.gov
 Patricia Conville
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5510
  Silver Spring MD 20993
  301/796-6942
  email: patricia.conville@fda.hhs.gov
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