# K162854: Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml

- Pathway: 510(k) (Traditional)
- Applicant: Liofilchem s.r.l.
- Decided: Dec 19, 2016 after 68 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 non-fastidious Gram negative and Gram positive aerobic bacteria (for example, Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococcus species) and fastidious bacteria (for example, anaerobes, Haemophilus and Streptococcus species and N. gonorrhoeae). 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 pg/mL of antimicrobial agents against v steria as tested on agar media using overnight incubation and manual reading procedures. The indications for use of this 510(k) is specifically for the Meropenem MTS at concentrations of 0.002 — 32 pg/mL. The non-fastidious bacteria that have been shown to be active both clinically and in vitro against meropenem according to the FDA label are: Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa

Source page: https://510kreport.com/device/K162854
Methodology: https://510kreport.com/methodology