USFDAAug 3, 2026, 05:27 PM
Intelligent Bio Solutions Completes Interference Study for Drug Screening 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, evaluated the system's accuracy and reliability when exposed to common external contaminants like hand creams, alcohol, and dirt, specifically assessing its ability to detect codeine. The successful completion of this study is a significant step towards the company's FDA 510(k) submission, which remains on track for the second half of 2026, aiming for entry into the U.S. drug screening market.
Key Highlights
- Intelligent Bio Solutions completed its Interference Study for the Intelligent Fingerprinting Drug Screening System.
- The study evaluated the impact of everyday substances (hand creams, alcohol, oils, dirt, water) on system accuracy.
- The objective was to demonstrate the system's ability to maintain codeine specificity despite external contaminants.
- Data analysis is underway, with independent verification via LC-MS/MS analysis.
- The study is a crucial step for the company's FDA 510(k) submission for U.S. market clearance for codeine detection.
- The company remains on track to submit its 510(k) package in calendar H2 2026.
- This moves the company closer to planned entry into the multi-billion-dollar U.S. drug screening market.
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