Hardy Diagnostics · Class II · Cleared Jun 26, 2025
| K-number | K250956 |
| Device name | HardyDisk AST Gepotidacin 10µg (GEP10) |
| Applicant | Hardy Diagnostics |
| Product code | JTN |
| Device class | Class II |
| Decision date | Jun 26, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 866.1620 |
The HardyDisk AST Gepotidacin 10µg (GEP10) is an antimicrobial susceptibility test disc used for semi-quantitative in vitro testing of bacterial susceptibility via the Kirby-Bauer agar diffusion method. It is specifically indicated for determining susceptibility of Enterobacterales, Staphylococcus saprophyticus, and Enterococcus faecalis to the antibiotic gepotidacin, with results interpreted using FDA Susceptibility Test Interpretive Criteria (STIC).
Not stated in this summary.
The device uses standardized agar diffusion test procedures (Kirby-Bauer method) as described in FDA Susceptibility Test Interpretive Criteria (STIC). The document references standardized methods for agar diffusion testing but does not cite specific ISO, IEC, or ASTM standard numbers.
Not stated in this summary. The document confirms substantial equivalence was determined for the stated indications of use and that the device is substantially equivalent to legally marketed predicate devices, but the document does not provide the comparative reasoning or specific predicate device information that would explain the substantial equivalence argument.
View the full FDA submission: accessdata.fda.gov