# K182922: MTS Omadacycline 0.002-32 µg/mL

- Pathway: 510(k) (Traditional)
- Applicant: Liofilchem s.r.l.
- Decided: Dec 14, 2018 after 56 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® MTS™ (MIC Test Strip) Omadacycline 0.002-32 pg/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 pg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS™ Omadacycline at concentrations of 0.002-32 pg/mL should be interpreted at 16-20 hours of incubation. MTS™ Omadacycline can be used to determine the MIC of omadacycline against the following bacteria. Omadacycline 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 Staphylococcus aureus Staphylococcus lugdunensis Enterococcus faecalis Gram-Negative bacteria Enterobacter cloacae Kilebsiella pneumoniae Omadacycline has been shown to be active in vitro only against the non-fastidious bacteria listed below according to the FDA drug approved label: Gram-Positive bacteria Enterococcus faecium (vancomycin-susceptible and -resistant isolates) Gram-Negative bacteria Escherichia coli Citrobacter freundi Citrobacter koseri Kilebsiella aerogenes Kilebsiella oxytoca

Source page: https://510kreport.com/device/K182922
Methodology: https://510kreport.com/methodology