Intelligent Fingerprinting, a subsidiary of Intelligent Bio Solutions, has received guidance from the U.S. Food and Drug Administration (FDA) on the regulatory classification of its Drug Screening Cartridge.
The FDA’s preliminary assessment places the cartridge under 21 CFR 862.3650, Opiate Test System – a Class II device that requires submission of a 510(k) pre-market notification and clearance prior to marketing. This feedback provides a clear regulatory pathway as Intelligent Fingerprinting prepares to expand into the U.S.
A Step Towards U.S. Expansion
Harry Simeonidis, President and CEO of Intelligent Bio Solutions, commented:
“Receiving the FDA’s preliminary assessment is an important milestone as we move towards introducing our technology to the U.S. market. With its portability, speed, and dignified approach, we believe fingerprint drug testing can help U.S. workplaces strengthen their safety programs while making testing simpler and more efficient.”
About the System
The Intelligent Fingerprinting Drug Screening System detects the presence of specific drugs and/or their metabolites using fingerprint sweat. The process is quick and hygienic, collecting ten fingerprint samples in less than a minute onto a tamper-evident cartridge. Results are available in ten minutes via the portable analysis unit.
Cartridges are designed to screen for multiple drug groups at once, including opioids, cocaine, methamphetamines, benzodiazepines, cannabis, methadone, and buprenorphine. The system offers employers a non-invasive, dignified, and rapid solution compared with traditional urine or saliva testing methods.
With more than 350 customers internationally, Intelligent Fingerprinting is already helping organizations deter substance misuse in the workplace, supporting employee safety, well-being, and compliance with health and safety policies.
