Thermo Fisher Scientific · Class II · Cleared Dec 5, 2024
| K-number | K242653 |
| Device name | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL |
| Applicant | Thermo Fisher Scientific |
| Product code | JWY |
| Device class | Class II |
| Decision date | Dec 5, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 866.1640 |
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid is an in vitro diagnostic device for clinical susceptibility testing of non-fastidious gram-positive bacterial isolates. It tests linezolid at dilution ranges of 0.25-32 µg/mL to determine antimicrobial susceptibility against organisms including Enterococcus faecium, Staphylococcus aureus, and related species.
Not stated in this summary. The document does not provide specific technological characteristics or design details comparing this device to its predicate devices.
Not stated in this summary. The document does not cite specific test methods or consensus standards such as ISO, IEC, or ASTM protocols.
Not stated in this summary. The FDA determination letter states the device is substantially equivalent but does not articulate the specific reasoning or predicate comparison that supports this conclusion. The document references a Predetermined Change Control Plan (PCCP) approval but does not explain the technical basis for substantial equivalence.
View the full FDA submission: accessdata.fda.gov