Intelligent Bio Solutions files FDA 510(k) for fingerprint drug screening codeine detection

INTELLIGENT BIO SOLUTIONS INC.

Submitted 510(k) to FDA on Sept 9, 2026 seeking clearance for opiate codeine detection via fingerprint sweat analysis.
Method Comparison Study: accuracy >98%, sensitivity >94%, specificity 100%, verified by LC-MS/MS across 3 U.S. clinical sites.
Package includes 18 test reports, 170+ attachments, 15,000+ data lines from 18,000+ hours of data collection.
Precision testing: 1,600+ tests across 3 production runs and 3 sites; cut-off study in 40 adults vs FDA-cleared predicate.
Cybersecurity: 100% of medium-risk vulnerabilities remediated; all 19 SBOM vulnerabilities resolved with third-party verification.

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