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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 7-178: CLSI M22-A3, quality control for commercially prepared microbiological culture media; approved standard - third edition. (InVitro Diagnostics)

Date of Standard: 2004. 
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:
Primary, Differential, Selective and non-selective microbiological culture media, IVDs
Processes Affected:
510(k), Pre-submission
Type of Standard:
 Horizontal, National
Extent of Recognition:
Complete standard with the following exception:

CLSI M22-A3 applies except when directions listed in product labeling differs from information in Tables 3 and 4 of the standard.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§866.2300 Culture Media, Non-Selective And Non-Differential Class 1 JSG
§866.2320 Culture Media, Multiple Biochemical Test Class 1 JSE
§866.2320 Culture Media, Non-Selective And Differential Class 1 JSH
§866.2320 Culture Media, Single Biochemical Test Class 1 JSF
§866.2330 Culture Media, Enriched Class 1 KZI
§866.2350 Culture Media, Antibiotic Assay Class 1 JSA
§866.2350 Culture Media, General Nutrient Broth Class 1 JSC
§866.2350 Culture Media, Vitamin Assay Class 1 JSB
§866.2350 Media, Culture, Amino Acid Assay Class 1 JRZ
§866.2360 Culture Media, Selective And Differential Class 1 JSI
§866.2360 Culture Media, Selective And Non-Differential Class 1 JSJ
§866.2360 Culture Media, Selective Broth Class 1 JSD
§866.2410 Culture Media, For Isolation Of Pathogenic Neisseria Class 2 JTY
FDA Technical Contacts:
 Alexandra Wong
  FDA/CDRH/OIR
  10993 New Hampshire Avenue Building 66, Room 5502
  Silver Spring MD 20993
  301/796-6210
  email: alexandra.wong@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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