# K260696: MTS Gepotidacin 0.016-256 µg/mL

- Pathway: 510(k) (Traditional)
- Applicant: Liofilchem s.r.l.
- Decided: Apr 17, 2026 after 45 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
Longest line of descent: 1 generation back to K153687 (2016). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153687: Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL, Liofilchem s.r.l. (2016) Summary page 5.

## Indications for use
The MTS (MIC Test Strip) Gepotidacin 0.016-256 μg/mL is a quantitative method intended for in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a predefined 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. MTS Gepotidacin at concentrations of 0.016-256 μg/mL should be interpreted at 16-20 hours of incubation. Testing with MTS Gepotidacin at concentrations of 0.016-256 μg/mL is indicated for Enterobacterales, Enterococcus faecalis, and Staphylococcus saprophyticus as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). The MTS Gepotidacin 0.016-256 μg/mL has demonstrated acceptable performance with the following organisms: Enterobacterales (Citrobacter freundii complex, Escherichia coli, and Klebsiella pneumoniae) Enterococcus faecalis Staphylococcus saprophyticus

Source page: https://510kreport.com/device/K260696
Methodology: https://510kreport.com/methodology