regulatory
confidence high
sentiment positive
materiality 0.60
Intelligent Bio Solutions completes usability study for FDA 510(k) submission for drug screening system
INTELLIGENT BIO SOLUTIONS INC.
- Study confirms system can be effectively administered by operators with no specialist background.
- Study conducted with CenExel Clinical Research; 15 operators participated.
- On track to submit 510(k) package in H2 2026 for U.S. market clearance for opiate codeine detection.
- Part of broader submission program including cut-off, method comparison, interference, and precision studies.
- Targets entry into the multi-billion-dollar U.S. drug screening market.