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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 7-217: CLSI M44-S3, zone diameter interpretive standards, corresponding minimal inhibitory concentration (mic) interpretive breakpoints, and quality control limits for antifungal disk diffusion susceptibility testing of yeasts; third informational supplement. (InVitro Diagnostics)

Date of Standard: 2009. 
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:
Antifungal Susceptibility minimum inhibitory concentration (MIC) and disk diffusion devices
Processes Affected:
510(k), Pre-suubmission
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
§866.1620 Discs, Elution Class 2 LTX
§866.1620 Susceptibility Test Discs, Antimicrobial Class 2 JTN
§866.1640 Susceptibility Test Plate, Antifungal Class 2 NGZ
§866.1700 Culture Media, Antifungal, Susceptibility Test Class 2 MJE
FDA Technical Contacts:
 Yvonne Shea
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5510
  Silver Spring MD 20993
  301/796-0576
  email: yvonne.shea@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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