Intelligent Bio Solutions completes method comparison study for fingerprint drug screening system ahead of FDA 510(k) filing
INBS•Next steps toward U.S. market entry
The company now shifts to final analysis and submission assembly, targeting an FDA 510(k) filing in the second half of 2026 to enter the U.S. market.
Clinical study completed ahead of FDA filing
Intelligent Bio Solutions completed a multi-site method comparison clinical study for its Intelligent Fingerprinting Drug Screening System to support an FDA 510(k) filing for codeine detection.
Results have not been presented yet; data analysis is underway with independent laboratory confirmation, ahead of inclusion in the FDA submission package.
Operational goal met in workplace screening settings
The study met its operational aim by showing typical workplace screening staff can use the system accurately in real-world screening settings.
