# K122359: Vitek 2 Strptococcus Ceftriaxone

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Aug 28, 2012 after 25 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.
1 later device descends from it; 1 cites it directly.
0 of 5 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 1.

## Most influential descendants
- K132507: Vitek 2 Ast ST Meropenem (2013), 0 descendants of its own

## Indications for use
VITEK® 2 Streptococcus Ceftriaxone is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK8 2 Streptococcus Ceftriaxone is a quantitative test intended for use with the VITEK® 2 and VITEK6 2 Compact Systems as a laboratory aid in the determination of in vitmo susceptibility to antimicrobial agents. Ceftriaxone has been shown to be active against most stra ins of the following microorganism, according to the FDA label for this antimicrobial. Active In Vitro and in Clinical Infections against: Streptococcus pneumbniae Streptococcus pyo genes Streptoccocus agalactiae viridans group streptococci The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System 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 spop. and clinically significant yeast.

Source page: https://510kreport.com/device/K122359
Methodology: https://510kreport.com/methodology