# K210287: VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Oct 28, 2021 after 268 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 K031865 (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)
- K121863: Vitek 2 Ast-ST Cefotaxime, bioMerieux, Inc. (2012) Summary page 4.

## Indications for use
VITEK® 2 AST-Streptococcus Cefotaxime is designed for antimicrobial susceptibility testing of Streptococcus spp. 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- Streptococcus Cefotaxime is a quantitative test. Cefotaxime 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: Streptococcus pneumoniae Streptococcus pyogenes (Group A beta-hemolytic streptococci)* Streptococcus spp. (Viridans group streptococci) *The VITEK® 2 Streptococcus Susceptibility Card also reports the susceptibility of the following additional organisms as listed on the FDA Susceptibility Test Interpretative Criteria website (STIC): Streptococcus spp. ß-Hemolytic Group (other than S. pyogenes). The VITEK® 2 Streptococcus Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of S. pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus to antimicrobial agents when used as instructed.

Source page: https://510kreport.com/device/K210287
Methodology: https://510kreport.com/methodology