# K113783: Vitek 2 Ast- Gram Postive Penicillin for Streptococcus Pneumoniae

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Aug 7, 2012 after 229 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.
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.

## Indications for use
VITEK® 2 AST - Gram Positive Penicillin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. VITEK 2 AST - Gram Positive Penicillin for Streptococcus pneumoniae is a quantitative test intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Penicillin has been shown to be active against most strains of the microorganism listed below, according to the FDA label for this antimicrobial. Streptococcus pneumoniae (pneumonia and meningitis) The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK 2 Compact 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 agalactiae, and S. pneumoniae.

Source page: https://510kreport.com/device/K113783
Methodology: https://510kreport.com/methodology