Aug. 5 at 12:46 PM
$INBS
The Usability Study forms part of the Company’s broader FDA 510(k) submission program, which also includes a Cut-off Study, Method Comparison Study, Interference Study, precision testing, and penetration testing. The Company remains on track to submit its 510(k) package in calendar H2 2026, as it progresses toward planned entry into the multi-billion-dollar U.S. drug screening market.
