Intelligent Bio Solutions Inc. Advances on FDA 510(k) Pathway with Biocompatibility Study Success

Core Insights - Intelligent Bio Solutions Inc. (INBS) has successfully completed a biocompatibility study for its Intelligent Fingerprinting Drug Screening System, a crucial step towards FDA 510(k) regulatory clearance [2][6][7] - The company aims to submit the 510(k) package in Q4 2024, with plans to bring the technology to the U.S. market in 2025 [3][6] Company Overview - INBS is a medical technology company focused on innovative, rapid, non-invasive testing solutions, particularly through its Intelligent Fingerprinting Drug Screening System [1][6] - The system utilizes fingerprint sweat analysis to screen for recent drug use, including opiates, cocaine, methamphetamine, and cannabis, providing results in under ten minutes [1][6] Technology and Applications - The Intelligent Fingerprinting Drug Screening System consists of a drug screening cartridge, a DSR-Plus reader, and a collection kit for laboratory analysis [3] - The technology is designed to be hygienic and cost-effective, making it suitable for safety-critical industries such as construction, manufacturing, transport, and drug treatment organizations [1][6] Regulatory Progress - The biocompatibility study adhered to ISO 10993 standards, confirming the safety of materials used in the drug screening system [2][6] - The FDA has approved the proposed testing approach for future premarket 510(k) submission, indicating a positive regulatory pathway for the company [7]