Thermo Fisher Scientific · Class II · Cleared Jun 30, 2025
| K-number | K250990 |
| Device name | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL |
| Applicant | Thermo Fisher Scientific |
| Product code | JWY |
| Device class | Class II |
| Decision date | Jun 30, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 866.1640 |
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin is an in vitro diagnostic device for clinical susceptibility testing of non-fastidious bacterial isolates. It tests ciprofloxacin at dilution ranges of 0.002-64 µg/mL against Enterobacterales and Pseudomonas aeruginosa to determine antimicrobial resistance patterns.
Not stated in this summary.
Not stated in this summary.
The device demonstrated acceptable performance with 13 Enterobacterales species and Pseudomonas aeruginosa. The FDA determination references legally marketed predicate devices predating the 1976 Medical Device Amendments or reclassified devices that do not require premarket approval. The substantial equivalence is based on the device meeting the same intended use and performance requirements as these predicates for antimicrobial susceptibility testing.
View the full FDA submission: accessdata.fda.gov