BioMérieux Submits 510(k) to FDA for New Gastrointestinal Panels

bioMérieux, a leader in in vitro diagnostics, has submitted its latest BIOFIRE® FILMARRAY® Gastrointestinal Panels to the U.S. FDA for 510(k) review. The GI1.1 Panel and GI1.1 Panel Mid are PCR molecular panels designed to detect 22 and 11 gastrointestinal pathogens, respectively, from a single sample with results in about one hour.

These panels address the persistent global issue of acute infectious gastroenteritis by providing more precise detection. Pathogens continue to evolve, necessitating advanced diagnostic tools to ensure timely and accurate results.

The panels feature enhanced capabilities, especially in norovirus detection, requiring only two minutes of hands-on preparation. They are compatible with bioMérieux’s BIOFIRE® FILMARRAY® systems, which facilitate rapid clinical decision-making.