| K-number | K251879 |
| Device name | Sulopenem SPM 2 µg |
| Applicant | Liofilchem |
| Product code | JTN |
| Device class | Class II |
| Decision date | Aug 12, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 866.1620 |
The Sulopenem SPM 2 μg is an in vitro antimicrobial susceptibility test disc used to determine if Enterobacterales bacteria are susceptible to the antibiotic sulopenem. It is applied to agar media and incubated overnight (16-18 hours) to produce a semi-quantitative result. The device was tested on 11 Enterobacterales species including E. coli, Klebsiella pneumoniae, and Proteus mirabilis.
Not stated in this summary.
The device is interpreted according to FDA Susceptibility Test Interpretive Criteria (STIC). Sulopenem at concentrations of 2 μg should be interpreted at 16-18 hours of incubation.
Not stated in this summary. The clearance letter states the device is substantially equivalent to legally marketed predicate devices but does not provide the specific comparative reasoning, performance data, or predicate device information in this summary document.
View the full FDA submission: accessdata.fda.gov