# K261853: Gepotidacin GEP 10 µg

- Pathway: 510(k) (Traditional)
- Applicant: Liofilchem, Inc.
- Decided: Jul 23, 2026 after 50 days
- Product code: JTN (Susceptibility Test Discs, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 866.1620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Gepotidacin GEP 10 μg is an in vitro semi-quantitative method for antimicrobial susceptibility of clinical isolates tested on agar media using overnight incubation. The Gepotidacin GEP 10 μg is intended to determine susceptibility of Enterobacterales, Enterococcus faecalis, and Staphylococcus saprophyticus to gepotidacin, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). Gepotidacin at a concentration of 10 μg should be interpreted at 16-18 hours of incubation. The Gepotidacin GEP 10 μg demonstrated acceptable performance with the following organisms: Enterobacterales (Citrobacter freundii, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Providencia rettgeri) Enterococcus faecalis Staphylococcus saprophyticus

Source page: https://510kreport.com/device/K261853
Methodology: https://510kreport.com/methodology