INTELLIGENT BIO SOLUTIONS INC. 8K

Intelligent Bio Solutions Inc. submitted a 510(k) premarket notification to the FDA seeking U.S. clearance for its Intelligent Fingerprinting Drug Screening System for codeine detection, backed by a comprehensive 2026 clinical and cybersecurity data package to support broader U.S. commercialization.

On September 9, 2026, Intelligent Bio Solutions Inc. announced that it has submitted a 510(k) premarket notification package to the U.S. Food and Drug Administration seeking clearance for its Intelligent Fingerprinting Drug Screening System to detect the opiate codeine, supported by an extensive multi-study clinical program conducted in 2026 across three independent U.S. clinical sites in partnership with Cliantha Research and CenExel Clinical Research, Inc. The submission includes method comparison, usability, interference, precision, and cut-off studies, as well as comprehensive cybersecurity software documentation, collectively demonstrating accuracy above 98%, sensitivity above 94%, 100% specificity, operational usability by non‑specialists, robustness to common workplace substances, repeatable performance, and resolution of all identified software vulnerabilities. FDA clearance, if obtained, is expected to enable the company to expand its current non-U.S. deployments and broaden its addressable market in the multi‑billion‑dollar U.S. drug screening market beyond Forensic Use Only settings, supporting its broader U.S. commercialization strategy.

Filing Facts

CIK

1725430

Ticker

-

Form

8K

Source Type

sec

Accession

0001493152-26-041901

Alert Tier

6