• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 7-228: CLSI M11-A8, methods for antimicrobial susceptibility testing of anaerobic bacteria; approved standard-eighth 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 Office and Division associated with recognized standards:
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
DIVISION OF MICROBIOLOGY (DMD)
Devices Affected:
Antimicrobial Susceptibility Systems Regulated Under 21 CFR 66.1640 and 866.1645
Processes Affected:
510(K), Pre-submission
Type of Standard:
 National, Horizontal
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 Manual Antimicrobial Susceptibility Test Systems Class 2 JWY
§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; Guidance for Industry and FDA
FDA Technical Contacts:
 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
 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
-
-