# K121546: Vitek 2 Gram Negative Doxycycline - Pathway: 510(k) (Traditional) - Applicant: bioMerieux, Inc. - Decided: Nov 20, 2012 after 179 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: 6 generations back to K032788 (2003). 6 ancestors in all. 15 later devices descend from it; 7 cite it directly. 1 of 22 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K103752: Vitek 2 Systems (PC) 5.02 Software, bioMerieux, Inc. (2011) Summary page 1. ## Most influential descendants - K161227: VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) (2016), 5 descendants of its own - K172731: VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) (2017), 3 descendants of its own - K183415: VITEK 2 AST-Gram Negative Imipenem (= 16 ug/mL) (2019), 2 descendants of its own - K193572: VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL) (2020), 1 descendant of its own - K163563: VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL) (2017), 1 descendant of its own ## Indications for use VITEK 2 Gram Negative Doxycycline is designed for antimicrobial susceptibility testing of Gram-negative bacilli. VITEK 2 Gram Negative Doxycycline is a quantitative test 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. Doxycycline 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 Acinetobacter species Enterobacter aerogenes Eseherichiacoli Kiebsiella species Shigelliaspecies The VITEK 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK 2 System 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 spp., S. pneumoniae, and clinically significant yeast. Source page: https://510kreport.com/device/K121546 Methodology: https://510kreport.com/methodology