# K260447: ETEST Gepotidacin (GEP) (0.016-256 µg/mL)

- Pathway: 510(k) (Traditional)
- Applicant: bioMérieux SA
- Decided: Apr 21, 2026 after 69 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K102668 (2010). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210757: ETEST Fosfomycin (FO) (0.032-512 µg/mL), Biomerieux S.A. (2021) Summary page 5.

## Indications for use
ETEST is a manual, quantitative technique for the determination of antimicrobial susceptibility of non‑fastidious Gram‑negative and Gram‑positive aerobic bacteria and fastidious bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC, in μg/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation. Testing with ETEST Gepotidacin (GEP) (0.016-256 μg/mL) is indicated for Enterobacterales, Staphylococcus saprophyticus, Enterococcus faecalis and Neisseria gonorrhoeae, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). ETEST Gepotidacin (GEP) (0.016-256 μg/mL) demonstrated acceptable performance with the following microorganisms: • Escherichia coli • Staphylococcus saprophyticus • Enterococcus faecalis • Neisseria gonorrhoeae

Source page: https://510kreport.com/device/K260447
Methodology: https://510kreport.com/methodology