# K073406: Vitek 2 Gram Negative Trimethoprim/Sulfamethoxazole

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Jan 23, 2008 after 50 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: 2 generations back to K032788 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041982: Vitek 2 Gram Negative Ertapenem, bioMerieux, Inc. (2004) Summary page 1.

## Indications for use
VITEK® 2 Gram Negative Trimethoprim/sulfamethoxazole is designed for antimicrobial susceptibility testing of gram-negative organisms and is 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. VITEK 2 Gram Negative Trimethoprim/sulfamethoxazole is a quantitative test. Trimethoprim/sulfamethoxazole 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 Escherichiacofi (including susceptible enterotoxigenic strains implicated in traveler's diarrhea) Klebsiella species Proteus mirabilis Enterobacter species Shigella flexneri Morganella morganfi Shigella sonnei Proteus vulgaris 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/K073406
Methodology: https://510kreport.com/methodology