# K032314: Vitek 2 Gram Positive Gatifloxacin

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Aug 22, 2003 after 25 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 2 Gram Positive AST Panel for Sparfloxacin: named in the summary without a submission number

## Indications for use
VITEK' 2 Gram Positive Gatifloxacin is designed for antimicrobial susceptibility testing of Staphylococcus aureus (methicillin susceptible strains only) and Staphylococcus saprophyficus. It is intended for use with the VITEK' 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

Source page: https://510kreport.com/device/K032314
Methodology: https://510kreport.com/methodology