# K091899: Vitek 2 Gram Negative Meropenem

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Aug 14, 2009 after 50 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: 4 generations back to K032788 (2003). 4 ancestors in all.
21 later devices descend from it; 2 cite it directly.
1 of 26 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082346: Vitek 2 Gram Negative Doripenem, bioMerieux, Inc. (2009) Summary page 2.

## Most influential descendants
- K103752: Vitek 2 Systems (PC) 5.02 Software (2011), 19 descendants of its own
- K121546: Vitek 2 Gram Negative Doxycycline (2012), 15 descendants of its own
- 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
- K220546: Colibrí System (2022), 2 descendants of its own

## Indications for use
VITEK® 2 Gram Negative Meropenem is designed for antimicrobial susceptibility testing of gram-negative microorganisms 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 Gram Negative Meropenem is a quantitative test. Meropenem has been shown to be active against most isolates of the following microorganisms listed below according to the FDA label for the antimicrobial. Active in vitro and in clinical infections: Escherichia coli Citrobacter diversus Pasteurella multocida Klebsiella pneumoniae, Citrobacter freundii Proteus vulgaris Pseudomonas aeruginosa, Enterobacter cloacae Salmonella species Proteus mirabilis, Hafnia alvei Serratia marcescens Acinetobacter species Klebsiella oxytoca Shigella species Aeromonas hydrophila Morganella morganii The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems 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 agalactiae, and S. pneumoniae.

Source page: https://510kreport.com/device/K091899
Methodology: https://510kreport.com/methodology