# K131779: Vitek 2 Ast-ST Tigecycline

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Oct 10, 2013 after 115 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)
- K111599: Vitek 2 Ast-ST Linezolid, bioMerieux, Inc. (2011)

## Indications for use
VITEI< 2 Streptooccus Tigecycline Is designed for antimicrobial susceptibility testing of Streptococcus species and is Intended for use with the VITEK* 2 and VITEK9 2 Compact Systems as a laboratory aid in the determination of Invitro susceptibility to antimicrobial agents. VITEKe 2 Streptococcus Tigecycline is a qualitative test. Tigecycline 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 Streptococcuspneunzoniae (penicillin-susceptible isolates) Streptococcus anginosus grp. (includes S. anginosus, S. interniedius. anid S. constellatus) Streptococcus agalactiae Streptococcus pyogenes The VITEK* 2 Antimicrobial Susceptibility Test (AST) Is Intended to be used with the VITEK8 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bac illi, Staphylococcus sppo., Enterococcus spp.. Streptococcusspp. and clinically significant yeast.

Source page: https://510kreport.com/device/K131779
Methodology: https://510kreport.com/methodology