# K153569: Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml

- Pathway: 510(k) (Traditional)
- Applicant: Liofilchem s.r.l.
- Decided: Jun 22, 2016 after 190 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 susceptiblilty 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 ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The purpose of the 510(k) is specifically for the dalbavancin MTS at concentrations of 0.002-32 ug/mL interpreted after 16-20 hours incubation. Dalbavancin has been shown to be active against the following bacteria, both clinically and in vitro according to the FDA label: Staphylococcus aureus (including methicillin resistant strains) Enterococcus faecalis (vancomycin susceptible strains)

Source page: https://510kreport.com/device/K153569
Methodology: https://510kreport.com/methodology