Intelligent Bio Solutions submits FDA 510(k) filing for fingerprint drug test system seeking codeine clearance
INBS•FDA filing seeks U.S. clearance for codeine detection
Intelligent Bio Solutions filed an FDA 510(k) application seeking U.S. clearance for its Intelligent Fingerprinting Drug Screening System to detect codeine.
The submission includes 2026 clinical data showing over 98% accuracy, over 94% sensitivity, and 100% specificity in a method comparison study.
Potential expansion beyond forensic-use-only settings
U.S. clearance would support entry into the multi-billion-dollar U.S. drug screening market beyond forensic-use-only settings.
