Intelligent Bio Solutions provides updated timeline for anticipated FDA 510(k) submission and clearance

Intelligent Bio Solutions Inc. (IBS) is advancing its mission to deliver intelligent, rapid, and non-invasive screening technologies, and has provided an update to its expected pathway for a U.S. Food and Drug Administration (FDA) 510(k) submission and potential clearance. While specifics were not disclosed, the revised timing underlines the company’s focus on aligning its flagship technologies with U.S. regulatory requirements and moving closer to potential U.S. market entry.

What the company builds

IBS operates across two core areas: its commercially available Intelligent Fingerprinting products and its development-stage Biosensor Platform. Together, these technologies aim to simplify point-of-care testing by making it faster, more accessible, and less invasive—without compromising on rigor.

Intelligent Fingerprinting: non-invasive drug screening

At the center of the company’s current offering is the Intelligent Fingerprinting Platform, a portable system that analyzes trace amounts of sweat from a fingerprint. The approach uses a single-use cartridge and a handheld reader, forming a compact, two-part workflow designed for on-site screening with minimal training.

The Intelligent Fingerprinting tests are designed to detect commonly abused substances, including:

• Opiates
• Cocaine
• Methamphetamines
• Benzodiazepines
• Cannabis
• Methadone
• Buprenorphine

This non-invasive collection method—no saliva, urine, or blood required—can streamline in-the-field screening for workplaces, treatment centers, law enforcement, and clinical settings. Its portability and ease of use aim to reduce logistical hurdles, help minimize chain-of-custody complexities, and support quicker decision-making where time and simplicity matter.

Biosensor Platform: a modular approach to point-of-care diagnostics

Beyond drug screening, the company is developing a versatile Biosensor Platform engineered to detect multiple biological analytes. The core concept is modularity: by swapping the enzyme layer that sits atop the sensor, the same underlying platform can be tuned to target different biomarkers.

IBS envisions building out a menu of point-of-care tests across key diagnostic categories, including:

• Clinical chemistry
• Immunology
• Tumor markers
• Allergens
• Endocrinology

This strategy could bring lab-like functionality closer to patients and providers, potentially enabling faster insights at the point of need while leveraging a common hardware and software backbone.

Regulatory pathway: updated 510(k) timing

In its latest update, Intelligent Bio Solutions outlined a revised timeline for an anticipated FDA 510(k) submission and potential clearance related to its Intelligent Fingerprinting technology. While the company did not share specific dates, the announcement signals ongoing progress across activities typically associated with 510(k) preparation, such as analytical and clinical validation, quality system readiness, and manufacturing controls.

For context, an FDA 510(k) is a premarket submission demonstrating that a device is substantially equivalent to a legally marketed predicate. Clearance is not guaranteed, and timelines can shift as companies complete testing, address feedback, and finalize documentation. Still, the updated outlook suggests IBS is moving forward with the steps necessary for potential U.S. commercialization.

Why it matters

• Speed and simplicity: Fingerprint-based sweat testing offers an alternative to traditional sample types, aiming to reduce collection time and handling complexity.
• On-site decisions: Portable readers can support rapid screening in workplaces, clinics, and community settings, potentially improving throughput and compliance.
• Platform potential: The Biosensor Platform’s modular design could unlock broader diagnostic menus across multiple clinical domains, leveraging the same underlying architecture.

What to watch next

• Validation data: Additional analytical and clinical performance results will be key to supporting regulatory submissions.
• Quality and manufacturing: Demonstrable quality management and scalable production are critical for both regulators and customers.
• Regulatory milestones: Progress updates on 510(k) submission status and subsequent FDA interactions will determine market timing.
• Partnerships and pilots: Collaborations with employers, healthcare providers, or public-sector programs could help demonstrate real-world impact.

Intelligent Bio Solutions’ updated 510(k) timeline underscores the company’s ambition to bring non-invasive, point-of-care diagnostics to more users, starting with its Intelligent Fingerprinting platform and expanding through a flexible biosensor ecosystem. As the regulatory process unfolds, the focus will remain on demonstrating reliability, usability, and clinical value across diverse environments.