Intelligent Bio Solutions Launches 135-Participant Multi-Site Study Measuring System Accuracy for FDA 510(k)
INBS•Intelligent Bio Solutions has begun a multi-site method comparison study with CenExel to validate sensitivity, specificity and accuracy of its Intelligent Fingerprinting Drug Screening System in 135 participants. The company expects enrollment and data collection to conclude by end of July 2026 for its FDA 510(k) submission.
1. Multi-Site Study Initiation
Intelligent Bio Solutions has partnered with CenExel Clinical Research to initiate a multi-site method comparison study designed to validate its fingerprint-based drug screening system for codeine detection. The study will involve typical workplace screening personnel to demonstrate ease of use by non-laboratory professionals.
2. Participant Enrollment and Diversity
A total of 135 donor participants will be enrolled and randomized into dosing groups reflecting U.S. population demographics. Nine operator participants representing human resources and occupational health staff will collect and analyze fingerprint sweat specimens under real-world conditions.
3. Performance Evaluation Metrics
The study will measure sensitivity, specificity and overall accuracy of the Intelligent Fingerprinting System, with independent confirmation via LC-MS/MS analysis. Demonstrating reliable results by intended end-users is a critical component of the FDA 510(k) submission.
4. Timeline and Regulatory Submission
Enrollment and data collection are slated to finish by the end of July 2026. Study results will be included in the company’s FDA 510(k) submission package alongside prior clinical cut-off data to pursue U.S. market clearance.
