| CLSI M11 9th Edition Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition. |
| Recognition Number | InVitro Diagnostics |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 7-286 |
| 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.
Susceptibility testing is indicated for any organism that contributes to an infectious process warranting antimicrobial chemotherapy if its susceptibility cannot reliably be predicted from existing antibiograms. Antimicrobial resistance patterns for many anaerobic bacteria have changed significantly over the last several years, resulting in a lack of predictability for many species. Susceptibility testing of anaerobes is recommended for surveillance purposes and for specific clinical situations.
Two end-point-determining susceptibility testing methods for anaerobic bacteria are described in Clinical and Laboratory Standards Institute document M11-A8 - Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard - Eighth Edition. The agar dilution method (Wadsworth) remains the reference standard, and is well suited for surveillance testing and research. It is also the standard to which other methods are compared. Broth microdilution is well suited for the clinical laboratory, but is currently limited to testing of Bacteroides fragilis group organisms and selected antimicrobial agents. QC criteria for each procedure are also described.
The tables in CLSI document M100,1 when used in conjunction with this standard, represent the most current information for drug selection, interpretation, QC, and antibiogram reports using the procedures standardized in M11. Users should replace tables published in earlier standards with these new tables. (Changes in the tables since the previous edition appear in boldface type). When new problems are recognized, or improvements in these criteria are made, changes will be incorporated into future editions of this standard and also distributed as informational supplements.
| Regulation Number | Device Name | Device Class | Product Code |
| SHORT-TERM ANTIMICROBIAL SUSCEPTIBILITY TEST (AST) SYSTEM | |||
| §866.1645 | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Class 2 | LON |
| §866.1640 | Manual Antimicrobial Susceptibility Test Systems | Class 2 | JWY |
| Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems, Issued March 2007. |