Intelligent Bio Solutions Files 8-K: Submits 510(k) to FDA for Codeine Test

What Happened

• On September 9, 2026, Intelligent Bio Solutions, Inc. (INBS) announced in a press release and Form 8-K that it submitted a 510(k) premarket notification to the U.S. Food and Drug Administration seeking regulatory clearance of its Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine. The press release is furnished as Exhibit 99.1 to the filing.

Key Details

• Filing date: September 9, 2026 (Form 8-K and press release).
• Regulatory action: Submission of a 510(k) premarket notification to the FDA.
• Product: Intelligent Fingerprinting Drug Screening System; targeted analyte: codeine (an opiate).
• Disclosure items reported: Regulation FD disclosure and Other Events (notification of the 510(k) submission).

Why It Matters

• This is a regulatory milestone: a 510(k) submission is the company’s formal step toward obtaining FDA clearance, which would be required for broader commercial use of the device in the U.S.
• The filing itself does not guarantee clearance, timing, or revenue; the company provided no financial results or commercialization timetable in this 8-K.
• Investors tracking INBS should view this as a product-development update that could affect future commercial prospects if the FDA grants clearance.