# K032399: Vitek 2 Gram Positive Moxifloxacin

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Sep 10, 2003 after 37 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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

## Most influential descendants
- K220803: VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 -  =8 µg/mL), VITEK 2 AST-GP Moxifloxacin (2023), 0 descendants of its own

## Recalls of this device
- Nov 9, 2022 · Class II · Z-0792-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- Nov 9, 2022 · Class II · Z-0843-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed

## Indications for use
VITEK 2® Gram Positive Moxifloxacin is designed for antimicrobial susceptibility testing of Staphylococcus aureus (methicillin-susceptible strains only). 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/K032399
Methodology: https://510kreport.com/methodology