| CLSI M45 3rd Edition Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria. |
| Recognition Number | InVitro Diagnostics |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 7-262 |
| 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.
If a bacterial pathogen's susceptibility to antimicrobial agents cannot be predicted based on the identity of the organism alone, in vitro antimicrobial susceptibility testing of the isolated organism may be indicated. Susceptibility testing is particularly necessary in those situations in which the etiological agent belongs to a bacterial species for which resistance to commonly used antimicrobial agents has been documented, or could arise.
A variety of laboratory techniques can be used to measure the in vitro susceptibility of bacteria to antimicrobial agents. Clinical and Laboratory Standards Institute document M45--Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria describes the standard microdilution and agar disk diffusion methods. It also includes a series of procedures designed to standardize test performance. The performance, applications, and limitations of the current CLSI-recommended methods are described.
| Regulation Number | Device Name | Device Class | Product Code |
| §866.1700 | Culture Media, Antimicrobial Susceptibility Test | Class 2 | LKA |
| §866.1700 | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | Class 2 | JSO |
| §866.1700 | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | Class 2 | JTZ |
| §866.1645 | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Class 2 | LON |
| §866.1640 | Manual Antimicrobial Susceptibility Test Systems | Class 2 | JWY |
| §866.1640 | Panels, Test, Susceptibility, Antimicrobial | Class 2 | LTT |
| §866.1640 | Solution, Antimicrobial | Class 2 | LOP |
| §866.1640 | Susceptibility Test Cards, Antimicrobial | Class 2 | LTW |
| §866.1640 | Susceptibility Test Powders, Antimicrobial | Class 2 | JTT |
| §866.1620 | Discs, Elution | Class 2 | LTX |
| §866.1620 | Susceptibility Test Discs, Antimicrobial | Class 2 | JTN |
| FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria: Antibacterial Susceptibility Test Interpretive Criteria https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm575163.htm |