# K042946: Vitek Gram Positive Susceptibility (GPS) Card for Rifampin

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Dec 7, 2004 after 42 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 FDA summary names its predicate without a number.
- (no number) VITEK Gram Positive Susceptibility (GPS) Card for Gatifloxacin: named in the summary without a submission number

## Indications for use
The VITEK® Gram Positive Susceptibility Test is intended to be used with the VITEK® 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 agalactiae,and S. pneurnoniae. VITEK® Gram Positive Rifampin is designed for antimicrobial susceptibility testing of Staphylococcus aureus and Staphylococcus epidermidis. VITEK Gram Positive Rifampin is for qualitative testing only. It is intended for use with the VITEK System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

Source page: https://510kreport.com/device/K042946
Methodology: https://510kreport.com/methodology