# K112075: Vitek 2 Strptococcus Ampicillin

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Sep 15, 2011 after 57 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 Streptococcus Ampicillin is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 Streptococcus Ampicillin 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. Ampicillin has been shown to be active against the microorganisms listed below: Beta-hemolytic group Streptococcus species Viridans group Streptococcus species The VITEK® 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/K112075
Methodology: https://510kreport.com/methodology