Medical Device Network

Intelligent Bio Solutions plans submission for 510(k) pre-market notification to the FDA

FDA offers guidance on regulatory classification of the Intelligent Fingerprinting Drug Screening Cartridge paving the way for Intelligent Bio Solutions expansion in the US.

US based medical technology company, Intelligent Bio Solutions Inc (INBS), has received guidance from the US Food and Drug Administration (FDA) on regulatory classification of its Intelligent Fingerprinting Drug Screening Cartridge.

The medical technology company specialises in smart non-invasive testing solutions, and with its Intelligent Fingerprinting Drug Screening Cartridge they can offer rapid testing of certain drugs.

To date, the FDA have provisionally classified the cartridge under 21 CFR 862.3650 as an Opiate Test System, a Class II device requiring a pre-market notification 510(k) submission and FDA clearance before being put on the market. This initial assessment opens the door for INBS to expand into the US, which is inline with its current growth strategy.

Following the guidance from the FDA INBS plans to submit a 510(k)-pre-market notification for its proprietary Intelligent Fingerprinting Drug Screening Cartridge.

Harry Simeonidis, President and CEO of Intelligent Bio Solutions, expressed his satisfaction with the FDA's preliminary assessment, stating, "We are pleased to receive the FDA's provisional classification for our Intelligent Fingerprinting Drug Screening Cartridge, which represents a significant milestone in our expansion into the US market. Our intelligent drug screening technology, with its fast collection time and portability, has the potential to redefine workplace testing by establishing a new standard for drug testing procedures that prioritize employee dignity while enhancing operational efficiency for employers."

The Intelligent Fingerprinting Drug Screening System detects the presence of specific drugs and their metabolites through fingerprint sweat analysis. Using a small, tamper-evident drug screening cartridge the device can collect ten fingerprint sweat samples in under a minute.

These tamper-proof cartridges are designed to simultaneously screen for multiple drug groups, including opioids, cocaine, methamphetamines, benzodiazepines, cannabis, methadone, and buprenorphine.

This non-invasive and rapid drug screening solution guarantees the employees well-being while maintaining workplace safety, while complying with health and safety policies. The technology has already gained positive feedback from INBS's customer base of over 350 clients in multiple countries.

At present the Intelligent Fingerprinting Drug Screening device is being used in the UK. In 2022 Goldstar Transport, a container haulier firm, purchased six Intelligent Fingerprinting portable readers and has been conducting random drug tests every month. Elsewhere in the UK glass manufacturer, Glass Systems, implemented the use of device for drug screening its employees.