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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 052 Date of Entry 07/15/2019 
FR Recognition Number 7-287
Standard
CLSI M44-S3 (2018)
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
Scope/Abstract
This standard provides approved zone interpretive criteria (breakpoints) for Candida species for caspofungin, fluconazole, and voriconazole after 20 to 24 hours incubation, as well as quality control parameters for caspofungin, fluconazole, posaconazole, and voriconazole. There are currently more than 10 systemically active antifungal agents, and it is expected that this document will further encourage the development of disk diffusion testing for at least some of these additional agents and genera.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
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
 Ribhi Shawar
  FDA/OC/CDRH/OPEQ/OIDRH/DMD/BAC1/
  301-796-6698
  ribhi.shawar@fda.hhs.gov
 Jeffrey Brocious
  FDA/OC/CDRH/OPEQ/OIDRH/DMD/BAC2/
  240-402-3797
  jeffrey.brocious@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
*These are provided as examples and others may be applicable.
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