# K113305: Vitek 2 Streptococcus Trimethoprim/Sulfamethoxazole

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Feb 10, 2012 after 93 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 Trimethoprim / Sulfamethoxazole is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 Streptococcus Trimethoprim / Sulfamethoxazole is a qualitative 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. Trimethoprim and Sulfamethoxazole have been shown to be active against most strains of the following microorganism, according to the FDA label for this antimicrobial. Active In Vitro and in Clinical Infections against: Streptococcus pneumoniae 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/K113305
Methodology: https://510kreport.com/methodology