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

Core Insights - Intelligent Bio Solutions Inc. (NASDAQ: INBS) has successfully completed biocompatibility testing for its Intelligent Fingerprinting Drug Screening System, a crucial step for FDA 510(k) regulatory clearance [7][12] - The company plans to submit the 510(k) package in Q4 2024, aiming to launch the technology in the U.S. market by 2025 [3][4] Company Overview - Intelligent Bio Solutions Inc. specializes in innovative, rapid, non-invasive testing solutions, focusing on drug screening through fingerprint sweat analysis [4] - The Intelligent Fingerprinting Drug Screening System is designed to be hygienic and cost-effective, screening for drugs commonly used in workplace settings, including opiates, cocaine, methamphetamine, and cannabis [4] - The system allows for sample collection in seconds and provides results in under ten minutes, making it a valuable tool for employers in safety-critical industries [4] Regulatory Progress - The biocompatibility study adhered to ISO 10993 standards, confirming that all materials in the system are safe for medical device use [2] - The testing protocol included cytotoxicity, sensitization, and irritation tests, which were approved by the FDA for future premarket 510(k) submission [8][12]