# K121100: Vitek 2 Ast Streptococus Vancomycin

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Nov 19, 2012 after 222 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: 1 (0 Class I)
- 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.
No later device cites it as a predicate yet.
0 of 4 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.

## Recalls of this device
- Nov 9, 2022 · Class II · Z-0848-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed

## Indications for use
VITEet 2 AST Streptococcus Vancomycin isdesigned for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 AST Streptococcus Vancomycin isa quantitative test intended for use with the VITEK® 2 and VITEK0 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Vancomycin 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 Viridans group streptococci In vitro data are available, but their clinical sgnificance is unknown Streptococcus agalaetiae Streptococcuspyogenes The VITEle 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 spp. and clinically significant yeast.

Source page: https://510kreport.com/device/K121100
Methodology: https://510kreport.com/methodology