# K192738: ETEST Delafloxacin (DFX) (0.002-32 µg/mL)

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux S.A.
- Decided: Nov 26, 2019 after 60 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: 4 generations back to K102668 (2010). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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 3.

## 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, in μg/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation. Delafloxacin has been shown to be active against the aerobic microorganisms listed below according to the FDA label for this antimicrobial agent. ETEST® DFX can be used to determine the MIC of Delafloxacin against the following microorganisms: Active both in vitro and in clinical infections: Gram-positive bacteria: • Staphylococcus aureus (including methicillin-resistant and methicillin-susceptible strains) • Staphylococcus haemolyticus • Staphylococcus lugdunensis • Enterococcus faecalis Gram-negative bacteria: • Pseudomonas aeruginosa

Source page: https://510kreport.com/device/K192738
Methodology: https://510kreport.com/methodology