# K191908: MTS Imipenem 0.016-256 µg/mL

- Pathway: 510(k) (Traditional)
- Applicant: Liofilchem s.r.l.
- Decided: Sep 4, 2019 after 50 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) Imipenem 0.016 - 256 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 pre-defined 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 Imipenem at concentrations of 0.016 - 256 μg/mL should be interpreted at 16-20 hours of incubation. Imipenem has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label: Gram-negative bacteria Citrobacter koseri Citrobacter freundii Enterobacter asburiae Enterobacter cloacae Escherichia coli Klebsiella aerogenes Klebsiella oxytoca Klebsiella pneumoniae Morganella morganii Proteus vulgaris Providencia rettgeri Serratia marcescens Acinetobacter baumannii Pseudomonas aeruginosa Imipenem has been shown to be active in vitro only against the non-fastidious bacteria listed below according to the FDA drug approved label: Gram-negative bacteria Providencia stuartii

Source page: https://510kreport.com/device/K191908
Methodology: https://510kreport.com/methodology