| CLSI M02 13th Edition Performance Standards for Antimicrobial Disk Susceptibility Tests |
| Recognition Number | InVitro Diagnostics |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 7-280 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | InVitro Diagnostics |
| FDA Tech | Patricia Conville FDA/OMPT/CDRH/OIR/DMD/BAC1/ 301-796-6942 patricia.conville@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This standard describes the reference agar disk diffusion method used to determine the in vitro antimicrobial susceptibility of bacteria that grow aerobically and includes: agar plate preparation; testing conditions including inoculum preparation and standardization, incubation time, and incubation temperature; results interpretation; QC procedures; and disk diffusion method limitations.
| Regulation Number | Device Name | Device Class | Product Code |
| §866.1620 | Discs, Elution | Class 2 | LTX |
| §866.1620 | Susceptibility Test Discs, Antimicrobial | Class 2 | JTN |
| Guidance for Industry and FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems, Issued August 2009. |