USFDAAug 3, 2026, 08:33 AM
Intelligent Bio Solutions Completes Key FDA Study for Drug System
AI Summary
Intelligent Bio Solutions Inc. announced the completion of its Interference Study for the Intelligent Fingerprinting Drug Screening System. This study, conducted with CenExel Clinical Research, Inc., evaluates the system's accuracy and reliability against common external contaminants and is a crucial step for the company's FDA 510(k) submission for U.S. market clearance for codeine detection. Data analysis is ongoing, and the company remains 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 Interference Study for Intelligent Fingerprinting Drug Screening System.
- Study supports FDA 510(k) submission for U.S. market clearance for codeine detection.
- Evaluated impact of external contaminants like hand creams, alcohol, oils, dirt, and water.
- Data analysis is underway, with independent verification via LC-MS/MS analysis.
- 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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