MTS Gepotidacin 0.016-256 µg/mL

The MTS Gepotidacin 0.016-256 µg/mL is a quantitative in vitro antimicrobial susceptibility test using specialized paper impregnated with a concentration gradient of the antibiotic gepotidacin. After applying the strip to inoculated Mueller-Hinton agar and incubating for 16-20 hours, the minimum inhibitory concentration (MIC) is read directly from the strip where the inhibition ellipse intersects the MIC scale. It is indicated for testing susceptibility of Enterobacterales, Enterococcus faecalis, and Staphylococcus saprophyticus.

Both the 510(k) device and predicate use high-quality paper impregnated with a predefined concentration gradient of antimicrobial agent, Mueller-Hinton agar, manual inoculation with 0.5 McFarland suspension, manual reading, and report results as MIC in µg/mL. The main differences are the antimicrobial agent (gepotidacin versus vancomycin) and incubation duration (16-20 hours versus 24 hours), which differ due to the specific agent and bacterial species tested.

The study design followed the CDRH Guidance for Industry and FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems (August 28, 2009). Quality control reference ranges were compared to CLSI M100-S35.