# K050976: Vitek 2 Gram Positive Trimethoprim/Sulfamethoxazole

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: May 23, 2005 after 35 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K050510: Echoview/Shimasonic Diagnostic Ultrasound System, Model Sdu-1100, Shimadzu Medical Systems (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
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. VITEK® 2 Gram Positive Trimethoprim/sulfamethoxazole is designed for antimicrobial susceptibility testing of Staphylococcus aureus. VITEK 2 Gram Positive Trimethoprim/sulfamethoxazole is a qualitative test. It 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.

Source page: https://510kreport.com/device/K050976
Methodology: https://510kreport.com/methodology