# K173817: Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL

- Pathway: 510(k) (Traditional)
- Applicant: Liofilchem s.r.l.
- Decided: Feb 28, 2018 after 75 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 o fantimicrobial susceptibility ofbacteria. MTS consists ofspecialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum 1nhi%)itory concentration (MIC) in pg/mL otg antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The Ceftazidime-avibactam MTS at concentrations of 0.016/4- 256/4 pg/mL should be interpreted at 16-20 hours of incubation. Ceftazidime-avibactam has been shown to be active both clinically and in vitro against the non-fastidious bacteria listed below Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa The following in vitro data are available but their clinical significance is unknown: Citrobacter koseri Enterobacter aerogenes Providencia stuartii

Source page: https://510kreport.com/device/K173817
Methodology: https://510kreport.com/methodology