# K181708: MTS Plazomicin 0.016-256 µg/mL

- Pathway: 510(k) (Traditional)
- Applicant: Liofilchem s.r.l.
- Decided: Jul 31, 2018 after 33 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® MTS™ (MIC Test Strip) 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 pg/mL of antimicrobial agents against bacteria as tested on agar media using overmight incubation and manual reading procedures. The MTS™ Plazomicin at concentrations of 0.016-256 pg/ml. should be interpreted at 16-20 hours of incubation. MTST™PLZ can be used to determine the MIC of plazomicin against the microorganisms listed in the table below: Plazomicin Activity According to the FDA Label Clinical and in vitro invitro only Enterobacter cloacae Citrobacter freundii Escherichiacoli Citrobacter koseri Klebs lella preurnoniae Klebsiella (Enterobacter) aerogenes Proteus mirabilis . Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcescens

Source page: https://510kreport.com/device/K181708
Methodology: https://510kreport.com/methodology