# K163083: VITEK 2 AST-GN Tobramycin (/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (/=16 ug/mL) - Pathway: 510(k) (Traditional) - Applicant: bioMerieux, Inc. - Decided: Feb 1, 2017 after 90 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: 1 generation back to K113200 (2012). 1 ancestor in all. No later device cites it as a predicate yet. 0 of 2 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K113200: Vitek 2 Ast-GN Piperacillin/Tazobactam, bioMerieux, Inc. (2012) Summary page 4. ## Indications for use VITEK® 2 AST-Gram Negative Tobramycin 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 Tobramycin is a qualitative test. Tobramycin 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: Citrobacter spp. Enterobacter spp. Escherichia coli Klebsiella spp. Morganella morganii Pseudomonas aetuginosa Proteus mirabilis Proteus vulgaris Providencia spp. Serratia spp. The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant acrobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. Source page: https://510kreport.com/device/K163083 Methodology: https://510kreport.com/methodology