# K112000: Vitek 2 Streptococcus Penicillin

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Oct 26, 2011 after 105 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.
3 later devices descend from it; 1 cites it directly.
0 of 7 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.

## Most influential descendants
- K232201: VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin (2023), 2 descendants of its own
- K260619: VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL) (2026), 0 descendants of its own
- K260281: VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (2026), 0 descendants of its own

## Indications for use
VITEK® 2 Streptococcus Penicillin is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 Streptococcus Penicillin 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. Active In Vitro and in Clinical Infections against: Beta hemolytic streptococci groups C and G Streptococcus pyo genes Streptococcus agalactiae Streptococcus viridans group Streptococcus pneurnoniae 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/K112000
Methodology: https://510kreport.com/methodology