# K193572: VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL) - Pathway: 510(k) (Traditional) - Applicant: bioMerieux, Inc. - Decided: Mar 13, 2020 after 81 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: 10 generations back to K032788 (2003). 10 ancestors in all. 1 later device descends 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) - K183415: VITEK 2 AST-Gram Negative Imipenem (= 16 ug/mL), bioMerieux, Inc. (2019) Summary page 3. ## Most influential descendants - K211136: VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) (2021), 0 descendants of its own ## Indications for use VITEK® 2 AST-Gram Negative Imipenem/Relebactam 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/Relebactam is a quantitative test. Imipenem/Relebactam 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: Klebsiella (Enterobacter) aerogenes Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa Citrobacter freundii Klebsiella oxytoca In vitro data are available, but clinical significance is unknown Citrobacter koseri Enterobacter asburiae 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/K193572 Methodology: https://510kreport.com/methodology