# K211672: MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL

- Pathway: 510(k) (Traditional)
- Applicant: Liofilchem s.r.l.
- Decided: Oct 20, 2021 after 141 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
MTS (MIC Test Strip) Piperacillin-tazobactam 0.016/4-256/4 μg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS™ consists of specialized paper impregnated with a predefined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in µg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. MTS Piperacillin-tazobactam (TZP) at concentrations of 0.016/4-256/4 μg/mL should be interpreted at 16-20 hours of incubation. MTS™ TZP can be used to determine the MIC of piperacillin-tazobactam against the following microorganisms for which piperacillin-tazobactam has been shown to be active clinically and/or in vitro according to the FDA drug approved label: Piperacillin-tazobactam has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label: Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa Acinetobacter baumannii Piperacillin-tazobactam has been shown to be active in vitro only against the non-fastidious bacteria listed below according to the FDA drug approved label: Citrobacter koseri Proteus mirabilis Serratia marcescens

Source page: https://510kreport.com/device/K211672
Methodology: https://510kreport.com/methodology