Intelligent Bio Solutions Inc. Submits 510(k) Premarket Notification to FDA for Drug Screening Technology

Intelligent Bio Solutions Inc. recently announced a significant achievement as it submitted a 510(k) premarket notification to the US Food and Drug Administration (FDA) for its Intelligent Fingerprinting Drug Screening System. The submission marks a critical step towards obtaining clearance for the innovative system following FDA review, as stated in a press release issued by the company on December 18, 2024.

The 510(k) submission included comprehensive performance data and validation studies, highlighting the System’s 94.1% accuracy and its reliability in drug detection using fingerprint sweat samples. These findings are essential as they demonstrate the system’s effectiveness and usability, positioning it well to cater to the increasing demand for efficient and non-invasive testing solutions in the US market.

The Intelligent Fingerprinting Drug Screening System holds promise not only for the US market but also for global expansion. Already adopted in international markets, the system has shown significant cost savings, operational efficiencies, and rapid results with minimal disruption. Its entry into the US market, one of the largest drug screening markets globally, is expected to drive revenue growth, market share expansion, and the formation of strategic partnerships for Intelligent Bio Solutions Inc.

Moreover, the System’s non-invasive nature and high accuracy make it a potentially disruptive technology for safety-critical industries such as construction, mining, and transportation. Beyond these sectors, applications in law enforcement, drug rehabilitation, and forensic fields offer additional revenue streams. The company’s expansion into the US market is anticipated to enhance its financial performance and solidify its position as a leader in pain-free testing solutions.

President and CEO at Intelligent Bio Solutions Inc., Harry Simeonidis, expressed enthusiasm about the 510(k) submission, emphasizing the team’s dedication in delivering the application and highlighting the transformative impact the technology can have in the drug screening market.

Designed for detecting drugs of abuse through fingertip sweat, the Intelligent Fingerprinting Drug Screening System delivers results within ten minutes, offering a non-invasive, hygienic, and user-friendly testing method. Its broad applicability across various industries and sectors underscores its potential market reach and impact.

Intelligent Bio Solutions Inc. (NASDAQ: INBS) specializes in innovative, rapid, non-invasive testing solutions and envisions revolutionizing portable testing through fingerprint sweat analysis. With swift sample collection and quick results, the technology is intended to benefit employers in safety-critical industries by detecting common drugs such as opiates, cocaine, methamphetamine, and cannabis.

For additional information about Intelligent Bio Solutions Inc., please visit their official website at http://www.ibs.inc/.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read GBS’s 8K filing here.

About GBS

GBS Inc operates as a biosensor diagnostic technology company in the Asia-Pacific and North America. It offers Saliva Glucose Biosensor, an organic thin-film transistor for diabetes management that measures glucose in saliva. The company also focuses on developing SARS-CoV-2 Biosensor, a biosensor test can be used as a complement to the (RNA) virus detection test; and a biosensor platform comprising of biochemistry, immunology, tumor markers, hormones, and nucleic acid diagnostic modalities.