MetaMedical™ Solutions Inc

Intelligent Bio Solutions seeks 510(k) approval with drug screening study

US-based medical technology company Intelligent Bio Solutions Inc (INBS) has teamed up with clinical research organisation (CRO) Cliantha Research to perform a study of its drug screening solution. 

The pharmacokinetic study aims to investigate the levels of opiates in fingerprint sweat, compared to blood, oral fluid, and urine samples. It will recruit 40 healthy adults and analyse the specimens using validated methods such as liquid chromatography, mass spectrometry (LC-MS/MS) and INBS’ Intelligent Fingerprinting Drug Screening System. 

Recruitment and screening of subjects for the study are scheduled for March and April 2024, followed by the commencement of studies in May 2024. Sample analysis is expected to conclude by June 2024. 

The Intelligent Fingerprinting Drug Screening System detects the presence of specific drugs and their metabolites using fingerprint sweat analysis. The device gathers ten fingerprint sweat samples in less than a minute, using a compact, tamper-evident cartridge.  

The study will be conducted under the company’s US Food and Drug Administration’s (FDA) 510(k) clinical study plan. 

In June 2023, the FDA categorised the cartridge as an Opiate Test System under 21 CFR 862, a Class II device requiring a pre-market notification 510(k) submission and FDA clearance for market release. The system is already being used in the UK, with container haulier company Goldstar Transport buying six of the Intelligent Fingerprinting portable readers in October 2022 for the random drug tests of its drivers, to adhere to fleet operator recognition scheme (FORS) guidelines. 

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The FDA evaluation paves the way for INBS to enter the US market, aligning with its growth strategy. 

In the announcement accompanying the study, INBS CEO Harry Simeonidis said: “We have developed a detailed plan that we are committed to executing, and while there is considerable work ahead, we have taken the crucial first step in this process.  

“Our focus is on ensuring we remain on track for our planned entry into the US market and expand access to our innovative screening solution.” 

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