Intelligent Bio Launches 75-Participant Interference Study for FDA 510(k) Codeine Test
INBS•Intelligent Bio Solutions has launched a 75-participant Interference Study to evaluate how common substances affect its Intelligent Fingerprinting system’s codeine detection accuracy. The study ends mid-July 2026, with its results forming part of the FDA 510(k) submission alongside Method Comparison and Cut-Off studies for U.S. clearance.
1. Interference Study Launch
Intelligent Bio Solutions has initiated an Interference Study with CenExel Clinical Research to assess its drug screening system’s specificity for codeine when subjects handle common interfering substances.
2. Study Protocol and Timeline
The protocol enrolls 75 healthy adults under both undosed and dosed conditions, uses multiple collection time points, and confirms results via LC-MS/MS analysis, with completion expected by mid-July 2026.
3. FDA Clearance Strategy
Results from this study, together with data from the ongoing Method Comparison and Cut-Off studies, will be compiled into the FDA 510(k) submission package to support planned U.S. market clearance.
