# K172542: Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL.

- Pathway: 510(k) (Traditional)
- Applicant: Liofilchem s.r.l.
- Decided: Oct 23, 2017 after 61 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 pg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The Tedizolid MTS at concentrations of 0.002- 32 pg/mL should be interpreted at 16-20 hours of incubation for non-fastidious organisms and 20-24 hours for fastidious organisms. Tedizolid has been shown to be active both clinically and in vitro against the non-fastidious bacteria listed below according to the FDA drug label: Staphylococcus aureus (including methicillin resistant and methicillin susceptible isolates) Enterococcus faecalis Tedizolid has been shown to be active both clinically and in vitro against the fastidious bacteria listed below according to the FDA drug label: Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus group (includes S. anginosus, S. constellatus, S. intermedius)

Source page: https://510kreport.com/device/K172542
Methodology: https://510kreport.com/methodology