# K180936: ETEST Telavancin (TLA) (0.002-32 ug/mL)

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux S.A.
- Decided: Jul 3, 2018 after 84 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: 3 generations back to K102668 (2010). 3 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151873: Etest Ceftaroline (0.002 - 32ug/ml), Biomerieux S.A. (2015) Summary page 4.

## Most influential descendants
- K192050: ETEST Eravacycline (ERV) (0.002 – 32 µg/mL) (2019), 2 descendants of its own
- 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
- K200512: ETEST Plazomicin (PLZ) (0.016-256 µg/mL) (2020), 0 descendants of its own
- K192738: ETEST Delafloxacin (DFX) (0.002-32 µg/mL) (2019), 0 descendants of its own

## Indications for use
ETEST® is a quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus, and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. 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 as tested on agar media using overnight incubation. Telavancin has been shown to be active against the Gram positive aerobic microorganisms listed below, according to the FDA label for this antimicrobial agent. Active both in vitro and in clinical infections: Staphylococcus aureus (including methicillin resistant isolates) Enterococcus faecalis (vancomycin susceptible isolates only)

Source page: https://510kreport.com/device/K180936
Methodology: https://510kreport.com/methodology