| CLSI M60 1st Edition Performance Standards for Antifungal Susceptibility Testing of Yeasts |
| Recognition Number | InVitro Diagnostics |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 7-217 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | InVitro Diagnostics |
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This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. Interpretive criteria and quality control parameters when different from that in FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria: Antifungal Susceptibility Test Interpretive Criteria. See relevant guidance below for information on interpretive criteria.
This document includes updated minimal inhibitory concentration, zone diameter, and quality control tables for the Clinical and Laboratory Standards Institute antifungal susceptibility testing documents M27 and M44.
| 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-Recognized Antimicrobial Susceptibility Test Interpretive Criteria: Antifungal Susceptibility Test Interpretive Criteria https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm575166.htm |