# K132507: Vitek 2 Ast ST Meropenem

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Nov 15, 2013 after 95 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)
- K122359: Vitek 2 Strptococcus Ceftriaxone, bioMerieux, Inc. (2012) Summary page 1.

## Indications for use
VITEK? 2 streptococcus Meropenemn is designed for antimicrobial susceptibility testing of Streptococcus spadies and is Intended for use with the VITEKO 2 and VITEK9 2 Compact Systems as a laboratory aid In the determination of In vitro susceptibility to antimicrobial agents. VITEI* 2 Streptococcus Meropenemn Is a quantitative test. Meropenemn has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vto and in clinical infections Streptococcus pneumonioe (penicillin-susceptible strains) Streptococcus agalacike Streptococcus pyogenes The VITEK* 2 Antimicrobial Susceptibility Test (AST) Is Intended to be used with the VITEK 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically. significant aerobic gram-negative bacilli, Staphylococcus sop., Entemecoccus spp.. Streptococcus spp. and clinically significant yeast.

Source page: https://510kreport.com/device/K132507
Methodology: https://510kreport.com/methodology