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Intelligent Bio Solutions submitted a 510(k) premarket notification to the U.S. Food and Drug Administration on…
INBSIntelligent Bio Solutions Inc.
Intelligent Bio Solutions submitted a 510(k) premarket notification to the U.S. Food and Drug Administration on September 9, 2026, seeking regulatory clearance for its Intelligent Fingerprinting Drug Screening System to detect codeine. The submission includes clinical data from over 18,000 hours of testing across three independent sites, demonstrating accuracy above 98%, sensitivity above 94%, and 100% specificity. The company operates in the medical technology industry, providing rapid, non-invasive drug screening solutions.