Clinical TrialJun 16, 2026, 04:37 PM
Intelligent Bio Solutions Starts FDA Interference Study for Codeine System
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, involving 75 healthy adults, aims to validate the system's specificity and reliability against potentially interfering substances. Expected to conclude by mid-July 2026, the results will be a crucial part of the comprehensive clinical package for FDA clearance.
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 codeine detection.
- It will assess the system's accuracy and reliability in the presence of potentially interfering substances.
- The study will enroll 75 healthy adult participants.
- Intelligent Bio Solutions expects to complete the study by mid-July 2026.
- Results will be included in the FDA 510(k) submission package, alongside data from other studies.
- The Interference Study runs concurrently with the Method Comparison Study and follows the Cut-off Study.
Price Impact
More from INBS