Intelligent Bio Solutions completes 1,600+ precision tests to bolster FDA 510(k) submission

Intelligent Bio Solutions completed precision testing of 1,600+ tests to strengthen its FDA 510(k) submission for codeine detection.

Key Highlights:

• Completed precision testing of more than 1,600 tests across three production runs and three independent sites.
• Results showed repeatable, reproducible performance, supporting suitability for workplace and other drug screening use.
• Precision data will be included in the FDA 510(k) submission alongside penetration, cut-off, method comparison, and interference studies.
• Company cites planned U.S. launch pending 510(k) clearance into a multi-billion-dollar U.S. drug screening market.

Original SEC Filing:

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