USFDAJun 16, 2026, 08:31 AM
Intelligent Bio Solutions Starts FDA Interference Study
AI Summary
Intelligent Bio Solutions Inc. announced the initiation of an Interference Study to support its FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for codeine detection. The study, conducted with CenExel Clinical Research, will assess the system's accuracy and reliability in the presence of potentially interfering substances, enrolling 75 healthy adult participants. This critical FDA-required study is expected to be completed by mid-July 2026, with results included in the FDA submission package alongside data from concurrent Method Comparison and prior Cut-off Studies.
Key Highlights
- Intelligent Bio Solutions initiated an Interference Study for its Intelligent Fingerprinting Drug Screening System.
- The study supports the FDA 510(k) submission for U.S. market clearance of the system for codeine detection.
- The Interference Study will assess system accuracy and reliability with potentially interfering substances.
- It will enroll 75 healthy adult participants, evaluated under undosed and dosed conditions.
- The company expects to complete the study by mid-July 2026.
- Results will be included in the FDA 510(k) submission package, along with other study data.
- The study is a critical FDA requirement to validate system specificity in real-world settings.
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