# K153687: Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL

- Pathway: 510(k) (Traditional)
- Applicant: Liofilchem s.r.l.
- Decided: Mar 31, 2016 after 99 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K260696: MTS Gepotidacin 0.016-256 µg/mL (2026), 0 descendants of its own
- K252114: MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL (2025), 0 descendants of its own
- K251580: MTS Sulbactam-Durlobactam  0.004/4 - 64/4 µg/mL (SUD) (2025), 0 descendants of its own

## Indications for use
The Liofilchem MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial suscpetibility of non-fastidious Gram negative and Gram positive acrobic 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 this 510(k) is specifically for the vancomycin MTS at concentrations of 0.016 - 256 ug/mL interpreted after 24 hours incubation. The non-fastidious bacteria that have been shown to be active both clinically and in vitro against vancomycin according to the FDA label are: Staphylococcus aureus and Staphylococcus epidermis (including methicillin resistant strains) Enterococcus faecalis Enterococcus faecium

Source page: https://510kreport.com/device/K153687
Methodology: https://510kreport.com/methodology