USFDAJul 21, 2026, 08:31 AM
Intelligent Bio Solutions Completes Precision Testing for FDA 510(k) Submission
AI Summary
Intelligent Bio Solutions Inc. announced the completion of precision testing for its Intelligent Fingerprinting Drug Screening System, a crucial step for its FDA 510(k) submission for U.S. market clearance for codeine detection. The testing involved over 1,600 tests across multiple sites and production runs, confirming consistent and reliable results. This data will strengthen the FDA application, bringing the company closer to entering the multi-billion-dollar U.S. drug screening market with its non-invasive technology.
Key Highlights
- Completed precision testing for Intelligent Fingerprinting Drug Screening System.
- Testing is a key component for FDA 510(k) submission for codeine detection.
- Over 1,600 tests conducted across three production runs and three independent sites.
- Results confirmed consistent, reliable, repeatable, and reproducible performance.
- Data will be included in FDA 510(k) submission, alongside other study data.
- U.S. drug screening market represents a multi-billion-dollar annual opportunity.
- Company is on track for FDA 510(k) submission and planned U.S. launch.
Price Impact
More from INBS