# K190154: ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux S.A.
- Decided: May 1, 2019 after 91 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K102668 (2010). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172150: Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL), bioMerieux, Inc. (2017) Summary page 3.

## Indications for use
ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC, in μg/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation. Piperacillin/Tazobactam has been shown to be active against the Gram-negative aerobic microorganisms listed below according to the FDA label for this antimicrobial agent. ETEST® P/T can be used to determine the MIC of Piperacillin/Tazobactam against the following microorganisms: Active both in vitro and in clinical infections: Acinetobacter baumannii Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa In vitro data are available for the following microorganisms, but clinical significance is unknown: Citrobacter koseri Morganella morganii Proteus mirabilis Proteus vulgaris Serratia marcescens Providencia stuartii Providencia rettgeri Salmonella enterica

Source page: https://510kreport.com/device/K190154
Methodology: https://510kreport.com/methodology