# K190616: VITEK 2 AST-Gram Positive Dalbavancin (<=  0.015 - >= 1 µg/mL)

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Jun 6, 2019 after 87 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: 3 generations back to K032766 (2003). 3 ancestors in all.
3 later devices descend from it; 3 cite 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)
- K141149: Vitek 2 Ast GP Ceftaroline, bioMerieux, Inc. (2014) Summary page 3.

## Most influential descendants
- K212243: VITEK 2 AST- Gram Positive Telavancin (<=0.015 -  >=1 µg/mL) (2022), 0 descendants of its own
- K202396: VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL) (2021), 0 descendants of its own
- K200590: VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL) (2020), 0 descendants of its own

## Indications for use
VITEK® 2 AST-Gram Positive Dalbavancin 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 Dalbavancin is a quantitative test. Dalbavancin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active both in vitro and in clinical infections Staphylococcus aureus (including methicillin-resistant isolates) Enterococcus faecalis (vancomycin-susceptible isolates only) Streptococcus agalactiae

Source page: https://510kreport.com/device/K190616
Methodology: https://510kreport.com/methodology