# K222378: VITEK 2 AST-Gram Negative Levofloxacin (/=8 ug/mL) - Pathway: 510(k) (Traditional) - Applicant: bioMerieux, Inc. - Decided: Jun 26, 2023 after 325 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: 3 generations back to K032788 (2003). 3 ancestors in all. No later device cites it as a predicate yet. 0 of 4 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K072038: Vitek 2 Gram Negative Levofloxacin, bioMerieux, Inc. (2007) Summary page 4. ## Indications for use VITEK® 2 AST-Gram Negative Levofloxacin is designed for antimicrobial susceptibility testing of Gram-negative bacilli and 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. VITEK® 2 AST-Gram Negative Levofloxacin is a quantitative test. Levofloxacin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens Active in vitro but clinical significance unknown: Citrobacter koseri, Citrobacter freundii, Enterobacter aerogenes, Klebsiella oxytoca, Morganella morganil, Pantoea agglomerans, Proteus vulgaris, Providencia rettgeri, Providencia stuartii VITEK® 2 AST-Gram Negative Levofloxacin also reports the susceptibility for the following additional organism as listed on the FDA Susceptibility Test Interpretive Criteria website: Salmonella spp. The VITEK® 2 Gram-Negative Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. Source page: https://510kreport.com/device/K222378 Methodology: https://510kreport.com/methodology