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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 7-230: CLSI M07-A9, methods for dilution antimicrobial susceptibility tests for bacteria that grow aerobically; approved standard - ninth edition. (InVitro Diagnostics)

Date of Standard: 2012. 
Address of Standards Development 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 IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
DIVISION OF MICROBIOLOGY (DMD)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
Antimicrobial Suceptibility Test Powder Regulated under 21 CFR 866.1640; Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Systems under 21 CFR 866.1645
Processes Affected:
510(K), Pre-submission
Type of Standard:
 Horizontal, National
Extent of Recognition:
Complete standard, with the exception of the interpretive criteria and quality control parameters when different from that in FDA approved drug labels. In the absence of the interpretive criteria and quality control parameters in FDA approved drug labels, consult the technical contacts.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§866.1640 Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Class 2 LRG
§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
§866.1645 System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Class 2 LON
Relevant Guidance:
Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems,
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
 Ribhi Shawar, Ph.D.
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5513
  Silver Spring MD 20993
  301/796-6698
  email: ribhi.shawar@fda.hhs.gov
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