# K183415: VITEK 2 AST-Gram Negative Imipenem (= 16 ug/mL) - Pathway: 510(k) (Traditional) - Applicant: bioMerieux, Inc. - Decided: Feb 20, 2019 after 72 days - Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation) - Device class: 2 - Regulation: 21 CFR 866.1645 - Recalls of this device: 1 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 9 generations back to K032788 (2003). 9 ancestors in all. 2 later devices descend from it; 1 cites it directly. 0 of 12 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K172731: VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL), bioMerieux, Inc. (2017) Summary page 4. ## Most influential descendants - K193572: VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL) (2020), 1 descendant of its own - K211136: VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) (2021), 0 descendants of its own ## Recalls of this device - Jan 5, 2026 · Class II · Z-1236-2026: Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identif ## Indications for use VITEK® 2 AST-Gram Negative Imipenem 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 Imipenem is a quantitative test. Imipenem 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 spp. Citrobacter spp. E.cloacae / E.cloacae complex Escherichia coli Klebsiella spp. Pseudomonas aeruginosa 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/K183415 Methodology: https://510kreport.com/methodology