# K073083: Vitek 2 Gram Negative Piperacillin

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Dec 10, 2007 after 39 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.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have 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.

## Indications for use
VITEK® 2 Gram Negative Piperacillin is designed for antimicrobial susceptibility testing of gram-negative organisms and is intended for use with the VITEK® 2 and VITEK® 2 Compact as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Systems VITEK 2 Gram Negative Piperacillin is a quantitative test. Piperacillin has been shown to be active against most strains of the organisms listed below according to the FDA label for the antimicrobial. Active in vitro and in clinical infections Acinetobacter species Morganella morganii Pseudomonas aeruginosa Enterobacter species Providencia rettgeri Serratia species Escherichia coli Proteus mirabilis Klebsiella species Proteus vulgaris Active in vitro but their clinical significance is unknown: Burkholderia cepacia Citrobacter freundii Citrobacter koseri (formerly C. diversus) Pseudomonas fluorescens 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 foe the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

Source page: https://510kreport.com/device/K073083
Methodology: https://510kreport.com/methodology