ETEST Gepotidacin (GEP) (0.016-256 µg/mL)

ETEST Gepotidacin (GEP) is a manual quantitative antimicrobial susceptibility test system that uses a predefined antibiotic gradient strip to determine the minimum inhibitory concentration (MIC) of gepotidacin against bacterial isolates. The device is indicated for testing Enterobacterales, Staphylococcus saprophyticus, Enterococcus faecalis, and Neisseria gonorrhoeae to assess their susceptibility to gepotidacin.

The device is a thin plastic strip with an MIC reading scale and preformed gepotidacin gradient (0.016-256 µg/mL) that transfers into agar. Key differences from the predicate (ETEST Fosfomycin) include the active antimicrobial agent (gepotidacin vs. fosfomycin), concentration range, and indicated organisms; the test methodology, design, and principles remain identical.

The device performance was compared to CLSI M07 12th Edition (March 2024) broth microdilution reference method, following FDA Class II Special Controls Guidance for Antimicrobial Susceptibility Test Systems (August 28, 2009), and adheres to CLSI M100 35th Edition (January 2025) specifications.

Substantial equivalence is based on identical test methodology, design, and operational principles to the predicate ETEST Fosfomycin device. Performance data demonstrates acceptable Essential Agreement (96.0–99.1%) and Category Agreement (99.3–100%) across four organism types, with reproducibility and quality control results comparable to or exceeding the predicate, supporting equivalent safety and effectiveness for its intended indications.