Intelligent Bio Solutions today announced the submission of its 510(k) premarket notification to the FDA for clearance of its Intelligent Fingerprinting Drug Screening System, a rapid method for drug screening. The company hopes to launch in the U.S. next year.
The company's 510(k) submission included performance data and validation studies, including a method comparison study that demonstrated the System’s 94.1% accuracy and a Pharmacokinetic (PK) study that showed fingerprint sweat provides a reliable sample matrix for drug detection, with quantitative PK data closely aligned to blood, based on statistical comparisons made at the 95% confidence level.
The System’s non-invasive design positions it to become an important technology for industries such as construction, mining, and transportation. Additionally, its application in the law enforcement, drug rehabilitation, and forensic sectors offers diverse revenue streams.
"The submission of our 510(k) application to the FDA is an impactful moment for all of us at Intelligent Bio Solutions, who have worked with perseverance and an intense focus to deliver our 510(k) package on time," said Harry Simeonidis, President and CEO at INBS. "Our team showed agility and resourcefulness, working with our clinical research partners to execute our clinical study plan and analyze the data. We are excited about our planned entry into the US market, the opportunities for growth, and the transformational impact that we believe we will have in the drug screening market with our innovative technology."
The Intelligent Fingerprinting Drug Screening System is designed to detect drugs of abuse through sweat collected from the fingertips and provide results within 10 minutes. This non-invasive, hygienic, and easy-to-administer test is particularly beneficial in safety-critical industries such as construction, transportation, mining, and logistics. The System has broader applicability across the law enforcement, drug rehabilitation, and forensic sectors, highlighting its vast market potential.
