# K200308: MTS Lefamulin 0.016- 256  µg/mL

- Pathway: 510(k) (Traditional)
- Applicant: Liofilchem S. R. 1.
- Decided: Apr 6, 2020 after 60 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 MTS (MIC Test Strip) Lefamulin 0.016 - 256 μg/mL 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 MTS Lefamulin at concentrations of 0.016 - 256 μg/mL should be interpreted at 16 - 20 hours (non-fastidious organisms) and 20 - 24 hours (fastidious organisms) of incubation. Lefamulin has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label: Gram-positive bacteria Streptococcus pneumoniae Staphylococcus aureus (methicillin-susceptible isolates) Gram-Negative bacteria Haemophilus influenzae

Source page: https://510kreport.com/device/K200308
Methodology: https://510kreport.com/methodology