# K173307: Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL

- Pathway: 510(k) (Traditional)
- Applicant: Liofilchem s.r.l.
- Decided: Dec 19, 2017 after 62 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
The Liofilchem® MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in pug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The Meropenem-vaborbactam MTS at concentrations of 0.016/8 - 256/8 pg/mL should be interpreted at 16-20 hours of incubation. Meropenem-vaborbactam has been shown to be active both clinically and in vitro against the non-fastidious bacteria listed below according to the FDA label: Enterobacter cloacae species complex Escherichia coli Klebsiella pneumoniae Meropenem/vaborbactam has been shown to be active in vitro against susceptible isolates of the following microorganisms: Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Klebsiella oxytoca Proteus mirabilis Providencia spp. Serratia marcescens

Source page: https://510kreport.com/device/K173307
Methodology: https://510kreport.com/methodology