Intelligent Bio Solutions Initiates Clinical Study Supporting FDA Clearance and Planned U.S. Market Entry
Intelligent Bio Solutions initiated an Interference Study to support its FDA 510(k) submission for the Intelligent Fingerprinting Drug Screening System, focusing on the detection of codeine. Partnering with CenExel Clinical Research, the study will enroll 75 healthy adults to validate the system's specificity against potentially interfering substances encountered in daily life.
Key figures
- Study type
- Interference Study
- Participants
- 75
- Target analyte
- codeine
- Submission type
- FDA 510(k)
- Completion expected
- mid-July 2026
AI analysis
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