# K082346: Vitek 2 Gram Negative Doripenem

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Mar 16, 2009 after 213 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: 3 generations back to K032788 (2003). 3 ancestors in all.
22 later devices descend from it; 1 cites 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)
- K072038: Vitek 2 Gram Negative Levofloxacin, bioMerieux, Inc. (2007) Summary page 1.

## Most influential descendants
- K091899: Vitek 2 Gram Negative Meropenem (2009), 21 descendants of its own
- 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

## Indications for use
VITEKO 2 Gram Negative Doripenem 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 is a quantitative test. Doripenem has been shown to be active against the microorganisms listed below according to the FDA label for the antimicrobial. Active in vitro and in clinical infections: Acinetobacter baumannii Escherichia coli Klebsiella pneumoniae Proteus mirabifis Pseudomonas aeruginosa Active in vitro but clinical significance unknown: Citrobacter freundii Enterobacter cloacae Enterobacter aerogenes Kiebsiella oxytoca Serratia marcescens The VITEKe 2 Antimicrobial Susceptibility Test (AST):is intended to be used with the VITEKe 2 and VITEKe 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/K082346
Methodology: https://510kreport.com/methodology