Intelligent Bio Solutions Inc. Completes Precision Testing for FDA 510(k) Submission

Intelligent Bio Solutions Inc. announced the completion of precision testing for its Intelligent Fingerprinting Drug Screening System, a crucial step for its FDA 510(k) submission for U.S. market clearance for the detection of the opiate codeine. The testing, which included over 1,600 tests across three production runs and three independent sites, demonstrated consistent and reliable results, confirming the system's suitability for drug screening environments. This data strengthens the company's submission package, which also includes data from previous studies on cut-off, method comparison, and interference. The company anticipates this will support their planned entry into the multi-billion-dollar U.S. drug screening market, offering advantages such as rapid, non-invasive testing. The system is designed for various applications including workplace testing, criminal justice, and pain management.