Intelligent Bio Solutions completes final clinical study; FDA 510(k) submission on track for H2 2026

INTELLIGENT BIO SOLUTIONS INC.

Completed multi-site Method Comparison Study; all clinical data collection for FDA 510(k) program now complete.
Study ran at 3 U.S. clinical sites over 3 weeks with CenExel; 135 participants and 9 operators enrolled.
Data analysis underway; all specimens independently verified via LC-MS/MS analysis.
FDA 510(k) submission targeted for H2 2026 for opiate codeine detection, ahead of planned U.S. market entry.
CEO Harry Simeonidis: milestone represents 'a substantial body of work and clinical evidence.'

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