# K211630: VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Aug 30, 2021 after 95 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: 1 generation back to K113200 (2012). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113200: Vitek 2 Ast-GN Piperacillin/Tazobactam, bioMerieux, Inc. (2012) Summary page 4.

## Indications for use
VITEK® 2 Gram Negative Piperacillin/tazobactam 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 Gram Negative Piperacillin/tazobactam is a quantitative test. Piperacillin/tazobactam has been shown to be active against the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections:Acinetobacter baumanii, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa (given in combination with an aminoglycoside to which the isolate is susceptible). In vitro data available but clinical significance is unknown: Citrobacter koseri, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Providencia rettgeri, Salmonella enterica. The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 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 spp., S. pneumoniae, and clinically significant yeast.

Source page: https://510kreport.com/device/K211630
Methodology: https://510kreport.com/methodology