Thermo Fisher Scientific · Class II · Cleared Feb 10, 2025
| K-number | K242905 |
| Device name | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL |
| Applicant | Thermo Fisher Scientific |
| Product code | JWY |
| Device class | Class II |
| Decision date | Feb 10, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 866.1640 |
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System is an in vitro diagnostic device for clinical susceptibility testing of fastidious bacterial isolates. This 510(k) specifically covers linezolid at a dilution range of 0.12-32 µg/mL for testing against Streptococcus pneumoniae, β-hemolytic streptococci, and viridans streptococci.
Not stated in this summary.
Not stated in this summary.
The FDA determined substantial equivalence by comparing this device to legally marketed predicate devices that existed prior to May 28, 1976, or to reclassified devices under the Federal Food, Drug, and Cosmetic Act. The device is classified as Class II (Antimicrobial Susceptibility Test Powder) under regulation 21 CFR 866.1640. The submission included a Predetermined Change Control Plan (PCCP) that was reviewed and cleared as part of the substantial equivalence determination, allowing for future modifications consistent with the PCCP without new premarket notification.
View the full FDA submission: accessdata.fda.gov