Core Viewpoint - Intelligent Bio Solutions Inc. is progressing towards the FDA clearance for its Intelligent Fingerprint Drug Screening System, aiming for a U.S. market launch in 2025, specifically targeting opiate testing for codeine [1][2][5]. FDA Clearance Process - The company submitted its 510(k) premarket notification to the FDA on December 18, 2024, marking a significant milestone for entering the U.S. market [2]. - The FDA classified the system as a Class II device, requiring a 510(k) submission, which initiated a 90-day review period [2][4]. - The FDA has issued an Additional Information (AI) request, pausing the review clock, and the company is currently addressing this request [4]. Performance Data - The 510(k) submission included performance data showing a 94.1% accuracy rate and validation studies indicating that fingerprint sweat is a reliable sample matrix for drug detection [3]. - The pharmacokinetic (PK) study results align closely with blood data, demonstrating the system's reliability and usability [3]. Market Potential - The company is preparing for a significant entry into the multi-billion-dollar U.S. market in 2025 and is also pursuing FDA clearance for additional drug classes [4]. - The Intelligent Fingerprinting Drug Screening System is designed for rapid, non-invasive testing, with results available in under ten minutes, making it suitable for safety-critical industries [6]. Global Presence - The company's full panel test is already adopted in 19 countries with over 400 accounts globally, indicating a strong international presence [4].
Intelligent Bio Solutions’ FDA Clearance Process Remains on Track for 2025 U.S. Launch