# K210757: ETEST Fosfomycin (FO) (0.032-512 µg/mL)

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux S.A.
- Decided: Nov 12, 2021 after 242 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: 5 generations back to K102668 (2010). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192050: ETEST Eravacycline (ERV) (0.002 – 32 µg/mL), Biomerieux S.A. (2019) Summary page 4.

## Most influential descendants
- K260447: ETEST Gepotidacin (GEP) (0.016-256 µg/mL) (2026), 0 descendants of its own

## 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. Fosfomycin has been shown to be active against the Gram-positive and Gram-negative aerobic microorganisms listed below according to the FDA label for this antimicrobial agent. ETEST® (FO) can be used to determine the MIC of Fosfomycin against the following microorganisms: Active both in vitro and in clinical infections: • Escherichia coli • Enterococcus faecalis

Source page: https://510kreport.com/device/K210757
Methodology: https://510kreport.com/methodology