# K251337: Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific (Oxoid Ltd.)
- Decided: Dec 5, 2025 after 219 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
Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, these discs are intended to determine susceptibility against microorganisms for which specific drugs have been shown to be active both clinically and in vitro. The Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 is intended to determine susceptibility of Enterobacterales, Staphylococcus saprophyticus, and Enterococcus faecalis to gepotidacin, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). The Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 demonstrated acceptable performance to determine susceptibility to gepotidacin against the following microorganisms: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Morganella morganii, Proteus mirabilis, and Providencia rettgeri) Staphylococcus saprophyticus Enterococcus faecalis

Source page: https://510kreport.com/device/K251337
Methodology: https://510kreport.com/methodology