INTELLIGENT BIO SOLUTIONS INC. Completes Precision Testing for FDA 510(k)

What Happened

• On July 21, 2026, Intelligent Bio Solutions Inc. (INBS) announced via a press release (furnished on Form 8-K) that it has completed precision testing, a key element of its FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine.

Key Details

• Date of disclosure: July 21, 2026 (Regulation FD disclosure reported on Form 8-K, Item 7.01).
• Product: Intelligent Fingerprinting Drug Screening System, specifically for detection of codeine.
• Milestone: Completion of precision testing—a required component of the company’s FDA 510(k) submission for U.S. clearance.
• Press release filed as Exhibit 99.1 to the Form 8-K.

Why It Matters

• Completion of precision testing is a concrete regulatory milestone on the path toward FDA 510(k) clearance, which is required for routine U.S. marketing of the device. For investors, this indicates progress in the company’s regulatory process that could enable commercial sales if subsequent review and clearance are successful. The filing itself is a disclosure of that progress, not an FDA approval or a guarantee of future results.