| CLSI M100 28th Edition Performance Standards for Antimicrobial Susceptibility Testing |
| Recognition Number | InVitro Diagnostics |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 7-281 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | InVitro Diagnostics |
| FDA Tech | Ribhi Shawar FDA/OMPT/CDRH/OIR/DMD/BAC1/ 301-796-6698 ribhi.shawar@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. Interpretive criteria and quality control parameters are not recognized when different from that in FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria: Antibacterial Susceptibility Test Interpretive Criteria. See relevant guidance below for information on interpretive criteria.
This standard includes updated tables for the CLSI antimicrobial susceptibility testing standards M02-A13, M07-A11, and M11-A8.
| Regulation Number | Device Name | Device Class | Product Code |
| §866.1645 | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Class 2 | LON |
| §866.1640 | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | Class 2 | LRG |
| §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 |
| FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria: Antibacterial Susceptibility Test Interpretive Criteria https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm575163.htm |