USFDAAug 5, 2026, 08:33 AM
Intelligent Bio Solutions Completes Usability Study for FDA 510(k)
AI Summary
Intelligent Bio Solutions Inc. announced the completion of its Usability Study for the Intelligent Fingerprinting Drug Screening System. This study is a crucial component of its FDA 510(k) submission program, seeking U.S. market clearance for the detection of codeine. The study, conducted with CenExel Clinical Research, evaluated the system's ease of use and operator training effectiveness, reinforcing its potential for broad adoption. The company is on track to submit its 510(k) package in H2 2026, targeting entry into the multi-billion-dollar U.S. drug screening market.
Key Highlights
- Completed Usability Study for Intelligent Fingerprinting Drug Screening System.
- Study supports FDA 510(k) submission for U.S. market clearance for codeine detection.
- Conducted with CenExel Clinical Research, following FDA guidance and ICH GCP standards.
- Evaluated operator training effectiveness and intuitive use in workplace settings.
- Fifteen operators participated without specialist knowledge or prior system experience.
- Company remains on track to submit 510(k) package in H2 2026.
- Aims for entry into the multi-billion-dollar U.S. drug screening market.
Price Impact
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