CLSI M44-A2 Vol. 29 No. 17 Replaces M44-A Vol. 24 No. 15

Method For Antifungal Disk Diffusion Susceptibility Testing Of Yeast; Approved Guideline-Second Edition

M44-A2 Vol. 29 No. 17 Replaces M44-A Vol. 24 No. 15

Standard Organization: CLSI

CLSI M44-A2 Vol. 29 No. 17 Replaces M44-A Vol. 24 No. 15
Method for Antifungal Disk Diffusion Susceptibility Testing of Yeast; Approved Guideline-Second Edition

Recognition NumberInVitro Diagnostics
Recognition Date2019-01-14
Recognition List051
Recognition Number7-215
Extent Complete standard
Standards Orgs CLSI Clinical Laboratory Standards Institute https://clsi.org/
STG InVitro Diagnostics
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Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

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.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§866.1700 Culture Media, Antifungal, Susceptibility Test Class 2 MJE
§866.1640 Susceptibility Test Plate, Antifungal Class 2 NGZ
§866.1620 Discs, Elution Class 2 LTX
§866.1620 Susceptibility Test Discs, Antimicrobial Class 2 JTN

FDA Guidance:

There is no relevant guidance developed at this time.

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