# K121863: Vitek 2 Ast-ST Cefotaxime

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Aug 16, 2012 after 51 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 K031865 (2003). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063597: Vitek 2 Gram Positive Amoxicillin for Streptococcus Pneumoniae, bioMerieux, Inc. (2007) Summary page 4.

## Most influential descendants
- K210287: VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL) (2021), 0 descendants of its own
- K132573: Vitek 2 Ast ST Moxifloxacin, Vitek 2 Ast Streptococcus Moxifloxacin (2013), 0 descendants of its own

## Indications for use
VITEK® 2 AST - ST Cefotaxime is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 AST - ST Cefotaxime is a quantitative test 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. Cefotaxime has been shown to be active against most strains of the microorganism 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. The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

Source page: https://510kreport.com/device/K121863
Methodology: https://510kreport.com/methodology