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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 029 FR Publication Date: 08/20/2012 

Part B: Supplementary Information

Recognition Number 7-198: CLSI M23-A3, development of in vitro susceptibility testing criteria and quality control parameters; approved guideline - third edition. (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:
IVDS
Processes Affected:
510(K), PMA, IDE, PDP
Type of Standard:
 National, Horizontal
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§866.1620 Discs, Elution Class 2 LTX
§866.1620 Susceptibility Test Discs, Antimicrobial Class 2 JTN
§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
§866.1640 Susceptibility Test Powders, Antimicrobial Class 2 JTT
§866.1640 Susceptibility Test Powders, Antimicrobial Class 2 JTT
§866.1640 Manual Antimicrobial Susceptibility Test Systems Class 2 JWY
§866.1640 Reagent/Device, Inoculum Calibration Class 2 LIE
§866.1640 Solution, Antimicrobial Class 2 LOP
§866.1640 Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Class 2 LRG
§866.1640 Panels, Test, Susceptibility, Antimicrobial Class 2 LTT
§866.1640 Susceptibility Test Cards, Antimicrobial Class 2 LTW
§866.1640 Susceptibility Test Powders, Antimycobacterial Class 2 MJA
§866.1640 System,Test,Genotypic Detection,Resistant Markers,Staphylococcus Colonies Class 2 MYI
§866.1640 Susceptibility Test Plate, Antifungal Class 2 NGZ
§866.1640 System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species Class 2 NIJ
§866.1640 System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen Class 2 NQX
§866.1645 System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Class 2 LON
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
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