# K132573: Vitek 2 Ast ST Moxifloxacin, Vitek 2 Ast Streptococcus Moxifloxacin

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Sep 13, 2013 after 28 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
VITEKO 2 Streptococcus Moxifloxacin is designed for antimicrobial susceptibility testing of Streptococcus species and is intended for use with the VITEKO 2 and VITEKO 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK* 2 Streptococcus Moxifioxacin Isa quantitative test. Moxifloxacin has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections Streptococcus anginasus Streptococcus consteilatus Streptococcus pneumnoniae (including multi-drug resistant Isolates [MDRSPJ*) Streptococcus pyc genes *MDRSP, Multi-drug resistant Streptococcus pneumronia. includes isolates previously known as PRSP (Penicillin resistant S. pneumonia.), and are isolates resistant to two or more of the following antibiotics: penicillin (MIC) k2 mcglmL). 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprimlsulfamethoxazole. The following in vitro data are available, but their clinical significance Is unknown. Grampositive bacteria Streptococcus agalactiae Streptococcus viridans group 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 bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.

Source page: https://510kreport.com/device/K132573
Methodology: https://510kreport.com/methodology