# K192050: ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux S.A.
- Decided: Sep 27, 2019 after 58 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K102668 (2010). 4 ancestors in all.
2 later devices descend 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)
- K180936: ETEST Telavancin (TLA) (0.002-32 ug/mL), Biomerieux S.A. (2018) Summary page 4.

## Most influential descendants
- K210757: ETEST Fosfomycin (FO) (0.032-512 µg/mL) (2021), 1 descendant of its own
- K260447: ETEST Gepotidacin (GEP) (0.016-256 µg/mL) (2026), 0 descendants of its own

## Recalls of this device
- Nov 9, 2022 · Class II · Z-0851-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed

## Indications for use
ETEST® is a manual, quantitative technique for 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, i ) of different antimicrobial agents against microorganisms tested on agar media using overnight incubation. Eravacycline has been shown to be active against most isolates of the microorganisms listed below according to the FDA label for this antimicrobial agent. ETEST® ERV can be used to determine the MIC of Eravacycline against the following microorganisms: Active both in vitro and in clinical infections: Gram-negative: Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Gram-positive: Enterococcus faecalis Enterococcus faecium In vitro data are available for the following microorganisms, but clinical significance is unknown: Citrobacter koseri Klebsiella aerogenes

Source page: https://510kreport.com/device/K192050
Methodology: https://510kreport.com/methodology