Thermo Fisher Scientific · Class II · Cleared Feb 10, 2025
| K-number | K243201 |
| Device name | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 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 penicillin testing in the concentration range of 0.015-32 µg/mL for organisms including Streptococcus pneumoniae and various Streptococcus species.
Not stated in this summary.
Not stated in this summary.
The device is substantially equivalent to legally marketed predicate devices that were on the market prior to May 28, 1976, or to devices that have been reclassified under the Federal Food, Drug, and Cosmetic Act. The FDA determined substantial equivalence based on comparison to these predicate devices for the stated indications of use, meaning the new device has the same intended use and technological characteristics as its predicates, thereby requiring only general controls rather than a premarket approval application.
View the full FDA submission: accessdata.fda.gov