Thermo Fisher Scientific · Class II · Cleared Sep 5, 2025
| K-number | K250575 |
| Device name | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL |
| Applicant | Thermo Fisher Scientific |
| Product code | JWY |
| Device class | Class II |
| Decision date | Sep 5, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 866.1640 |
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam is an in vitro diagnostic device for clinical susceptibility testing of non-fastidious gram-negative bacterial isolates. It tests Enterobacterales organisms using aztreonam/avibactam in the dilution range of 0.008/4-64/4 µg/mL to determine antimicrobial susceptibility.
Not stated in this summary. The document does not provide comparative technological characteristics between this device and its predicate device.
Not stated in this summary. The document does not cite specific ISO, IEC, ASTM, or other consensus standards for testing.
Not stated in this summary. While the FDA determined substantial equivalence to legally marketed predicate devices or reclassified devices, the clearance letter does not articulate the specific reasoning or comparison basis for this determination. The document references an enclosure containing indications for use but does not explain the predicate device comparison or performance equivalence argument.
View the full FDA submission: accessdata.fda.gov