Intelligent Bio Solutions & Cliantha Research: FDA 510(k) PK Study

Photo:Representative Image

Intelligent Bio Solutions Inc., a medical technology company delivering smart, rapid, non-invasive testing solutions, has announced its partnership with Cliantha Research, a full-service clinical research organization, to perform a pharmacokinetic (PK) study forming part of the company’s US FDA 510(k) clinical study plan.

The company’s pharmacokinetic study will recruit 40 healthy adult subjects under an IRB/EC and regulatory-approved protocol and compare the amounts of opiates in fingerprint sweat versus blood, oral fluid and urine specimens following the medically supervised administration of drugs.

All fingerprint sweat, blood, oral fluid and urine specimens will be analyzed by a validated, traceable liquid chromatography-mass spectrometry (LC-MS/MS) method, widely accepted as the gold standard for such studies. 

The fingerprint sweat specimen will be screened using INBS’s Intelligent Fingerprinting Drug Screening System, comprising the Intelligent Fingerprinting Drug Screening Cartridge and DSR-Plus fluorescence reader, and compared to the LC-MS/MS results.

The start of the clinical study plan marks an exciting milestone for the company as it advances on its 510(k) pathway. Harry Simeonidis, president and CEO at Intelligent Bio Solutions, commented, “We are pleased to share news of our partnership with Cliantha and progress on our 510(k) journal.

Initiating our clinical studies plan represents a critical milestone for our organization. We have drawn up a detailed plan we are working hard to implement. Although much work remains, we have taken the first steps in this direction. "Our focus is on keeping our US market entry plans on track and expanding access to new surveillance solutions." 

Anne Marie Salapatek, Ph.D., Chief Scientific Officer and Executive Vice President of Cliantha Research, said: "We are excited to begin a robust, controlled clinical trial at Cliantha to test the potential of this innovative device and provide a rapid, non-invasive testing method. We are pleased."

In June 2023, the company announced that it had received guidance from the US FDA regarding the regulatory classification of the cartridge. 

Smart Finger Drug Recognition The FDA has determined that the cartridge is Class II. The device is under 21 CFR 862.3650, Opioid Testing System, which requires FDA 510(k) premarket notification and approval.