Intelligent Bio Solutions starts multi-site FDA 510(k) study for opiate codeine fingerprint test

INTELLIGENT BIO SOLUTIONS INC.

Study will enroll 135 donor participants across multiple sites; partnered with CenExel Clinical Research.
Designed to validate accuracy, sensitivity, specificity of the Intelligent Fingerprinting Drug Screening System for workplace use.
Company expects to complete enrollment and data collection by end of July 2026.
User performance evaluation by non-laboratory personnel is a key part of the 510(k) submission.
Results will be confirmed via LC-MS/MS; study follows ICH GCP guidelines.

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