Intelligent Bio Solutions Commences Multi-Site Method Comparison Study for FDA 510(k) Submission
Intelligent Bio Solutions has commenced a multi-site Method Comparison Study to support its FDA 510(k) submission for the Intelligent Fingerprinting Drug Screening System. The study, conducted in partnership with CenExel Clinical Research, will enroll 135 participants and evaluate the system's accuracy when operated by typical workplace personnel without specialized training.
Key figures
- Drug Name
- Intelligent Fingerprinting Drug Screening System
- Phase Of Trial
- Method Comparison Study
- Operator count
- 9
- Completion target
- end of July 2026
- Participant count
- 135
AI analysis
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