# K170772: Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL

- Pathway: 510(k) (Traditional)
- Applicant: Liofilchem s.r.l.
- Decided: Jun 7, 2017 after 85 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 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. The Clindamycin MTS at concentrations of 0.016-256 μg/mL should be interpreted at 16-20 hours of incubation. The non-fastidious bacteria that have been shown to be active both clinically and in vitro against Clindamycin according to the FDA label are: Staphylococcus aureus (methicillin-susceptible strains)

Source page: https://510kreport.com/device/K170772
Methodology: https://510kreport.com/methodology