USFDAJun 2, 2026, 08:56 AM
Intelligent Bio Solutions Starts FDA Study for Fingerprinting Drug System
AI Summary
Intelligent Bio Solutions Inc. announced the initiation of a multi-site Method Comparison Study to support its FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for codeine. The study, conducted in partnership with CenExel Clinical Research, Inc., will evaluate the system's accuracy and real-world performance by typical end-users. The company expects to complete enrollment and data collection by the end of July 2026, with results to be included in its FDA submission.
Key Highlights
- Intelligent Bio Solutions initiated a multi-site Method Comparison Study for its Intelligent Fingerprinting Drug Screening System.
- The study supports FDA 510(k) submission for U.S. market clearance of the system for opiate codeine.
- The company partnered with CenExel Clinical Research, Inc. to perform the study.
- The study will enroll 135 donor participants and involve nine operator participants.
- It aims to validate the system's accuracy and real-world workplace performance by end-users.
- Enrollment and data collection are expected to be completed by the end of July 2026.
- Results will be included in the FDA 510(k) submission package, alongside prior clinical cut-off study data.
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