# K212849: VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)

- Pathway: 510(k) (Special)
- Applicant: Biomérieux, Inc.
- Decided: Feb 4, 2022 after 150 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: 1 generation back to K032766 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032766: Vitek 2 Gram Positive Linezolid, bioMerieux, Inc. (2003) Summary page 4.

## Indications for use
VITEK® 2 AST-Gram Positive Linezolid 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 Gram Positive Linezolid is a quantitative test. Linezolid 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: Enterococcus faecium (vancomycin-resistant isolates only) Staphylococcus aureus (including methicillin-resistant isolates) Streptococcus agalactiae In vitro data available but clinical significance is unknown: Enterococcus faecalis (including vancomycin-resistant isolates) Enterococcus faecium (vancomycin-susceptible isolates) Staphylococcus epidermidis (including methicillin-resistant isolates) Staphylococcus haemolyticus 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/K212849
Methodology: https://510kreport.com/methodology