Thermo Fisher Scientific · Class II · Cleared Jun 20, 2025
| K-number | K242843 |
| Device name | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. |
| Applicant | Thermo Fisher Scientific |
| Product code | JWY |
| Device class | Class II |
| Decision date | Jun 20, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 866.1640 |
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole is an in vitro diagnostic device for clinical susceptibility testing of fastidious bacterial isolates. It tests Streptococcus pneumoniae and Streptococcus pyogenes using ceftobiprole at dilution ranges of 0.008-16 µg/mL to determine antimicrobial susceptibility.
Not stated in this summary.
Not stated in this summary.
The device is substantially equivalent to legally marketed predicate devices that predate May 28, 1976, or to reclassified devices not requiring premarket approval. The FDA's determination is based on comparison of indications for use and demonstrated acceptable performance with the specified organisms, though the specific predicate device name and detailed comparison reasoning are not disclosed in this clearance letter.
View the full FDA submission: accessdata.fda.gov