# K200590: VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Apr 28, 2020 after 53 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- 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 K032766 (2003). 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)
- K190616: VITEK 2 AST-Gram Positive Dalbavancin (<=  0.015 - >= 1 µg/mL), bioMerieux, Inc. (2019) Summary page 3.

## Indications for use
VITEK® 2 AST-Gram Positive Delafloxacin is designed for antimicrobial susceptibility testing of Gram positive microorganisms and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Positive Delafloxacin is a quantitative test. Delafloxacin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Acute Bacterial Skin and Skin Structure Infections (ABSSSI): Staphylococcus aureus (including methicillin-resistant and methicillin-susceptible isolates) Streptococcus agalactiae Enterococcus faecalis Community-Acquired Bacterial Pneumonia (CABP): Staphylococcus aureus (methicillin-susceptible isolates only) The VITEK® 2 Gram-positive Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.

Source page: https://510kreport.com/device/K200590
Methodology: https://510kreport.com/methodology