# K072038: Vitek 2 Gram Negative Levofloxacin

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Sep 12, 2007 after 49 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.
26 later devices descend from it; 4 cite it directly.
1 of 29 devices in its family (counting itself) has 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.

## Most influential descendants
- K082346: Vitek 2 Gram Negative Doripenem (2009), 22 descendants of its own
- K091899: Vitek 2 Gram Negative Meropenem (2009), 21 descendants of its own
- K103752: Vitek 2 Systems (PC) 5.02 Software (2011), 19 descendants of its own
- K121546: Vitek 2 Gram Negative Doxycycline (2012), 15 descendants of its own
- K161227: VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) (2016), 5 descendants of its own

## Indications for use
VITEK® 2 Gram Negative Levofloxacin is designed for antimicrobial susceptibility testing of Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter baumannii, Acinetobacter lwoffii, Citrobacter koseri, Citrobacter freundii, Enterobacter aerogenes, Enterobacter sakazakii, Klebsiella oxytoca, Morganella morganii, Pantoea agglomerans, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas fluorescens. VITEK 2 Gram Negative Levofloxacin is a quantitative 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. 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/K072038
Methodology: https://510kreport.com/methodology