Thermo Fisher Scientific (Oxoid Ltd.) · Class II · Cleared Jun 12, 2025
| K-number | K250789 |
| Device name | Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 |
| Applicant | Thermo Fisher Scientific (Oxoid Ltd.) |
| Product code | JTN |
| Device class | Class II |
| Decision date | Jun 12, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 866.1620 |
The Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 is an antimicrobial susceptibility test disc used in semi-quantitative agar diffusion testing to determine bacterial susceptibility to the antibiotic combination aztreonam/avibactam. It is intended for in vitro diagnostic use to help clinicians select appropriate antibiotic treatments for patients with suspected microbial infections, specifically for testing Enterobacterales species.
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The device is substantially equivalent to legally marketed predicate devices that predate the Medical Device Amendments (May 28, 1976) or to reclassified devices. The applicant demonstrated that the Aztreonam/Avibactam disc achieved acceptable performance in determining susceptibility against seven specified Enterobacterales species using the FDA's recognized Susceptibility Test Interpretive Criteria (STIC). The clearance was granted under 21 CFR 866.1620 (Antimicrobial Susceptibility Test Disc regulation), indicating the device meets the same regulatory classification and intended use requirements as existing predicate antimicrobial susceptibility test discs.
View the full FDA submission: accessdata.fda.gov