Intelligent Bio Solutions Completes Codeine Detection Study in 40 Adults, Advances FDA 510(k) Program
Intelligent Bio Solutions completed its clinical cut-off study evaluating codeine detection in 40 adults as planned, confirming results against an FDA-cleared device and LC-MS/MS analysis. The company initiated a multi-site method comparison and usability study through June and an interference study through July en route to its FDA 510(k) submission.
1. Completion of Clinical Cut-off Study
Intelligent Bio Solutions finalized its initial clinical cut-off study on schedule by the end of March 2026, enrolling 40 adult participants to assess codeine detection thresholds. Results were benchmarked against an FDA-cleared predicate device and validated through liquid chromatography-tandem mass spectrometry (LC-MS/MS), confirming the system’s accuracy at designated cut-off levels.
2. Initiation of Phase Two Clinical Program
Following the cut-off study, the company launched a multi-site Method Comparison and Usability Study to span several clinical locations, assessing real-world operator performance and workflow integration. In parallel, an Interference Study will test the fingerprint screening system against common potential interferents, with completion targeted by end-July 2026.
3. U.S. Market Opportunity and Technology Advantages
Intelligent Bio Solutions is positioning its non-invasive fingerprint drug screening for U.S. market clearance under 510(k), addressing a multi-billion-dollar annual market including workplace, criminal justice, pain management and substance abuse sectors. The platform’s rapid, on-site detection of current impairment via sweat analysis offers hygienic, portable testing with under ten-minute results, potentially disrupting traditional urine and oral fluid methods.