Intelligent Bio Solutions Inc. has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) to seek regulatory clearance for its Intelligent Fingerprinting Drug Screening System, a tool designed to detect codeine through sweat analysis. The submission includes clinical data gathered from studies conducted in 2026 in collaboration with Cliantha Research and CenExel Clinical Research, Inc., adhering to FDA guidance and International Council for Harmonisation Good Clinical Practice standards.
The system’s performance metrics demonstrate high accuracy: a method comparison study showed sensitivity above 94%, specificity of 100%, and overall accuracy exceeding 98%. Additionally, usability testing confirmed the system can be operated by individuals without prior laboratory experience, while interference studies confirmed its reliability across everyday substances like hand creams, alcohol-based products, and oils. Precision testing validated repeatable performance across over 1,600 tests conducted across three production runs and three independent sites.
The submission package comprises 18 test reports, over 170 supporting attachments, and more than 15,000 lines of analyzed data. The technology, currently deployed in select international markets for workplace, law enforcement, and government use, screens for recent drug use—including opiates, cocaine, methamphetamine, and cannabis—with results available in under ten minutes. Cybersecurity and software vulnerabilities were also addressed, with all medium-risk cybersecurity issues and 19 software bill-of-materials vulnerabilities resolved through independent verification.
While the system is not yet FDA-cleared for U.S. use, its deployment in other countries underscores its potential to expand into new regulatory markets. The submission reflects the company’s ongoing efforts to refine and scale its fingerprint-based drug screening technology, which could broaden its applications beyond existing approvals.
