Intelligent Bio Solutions Inc. provided a status update on the FDA clearance process for its Intelligent Fingerprint Drug Screening System, confirming it remains on track for a U.S. launch in 2025. The FDA classified the system as a Class II device, requiring a 510(k) premarket notification.
Following the December 18, 2024, submission, the FDA issued an Additional Information (AI) request, which pauses the 90-day review clock. The company is actively reviewing and responding to the AI request, noting that such requests are not uncommon and the clearance process can take three to six months or longer.
INBS remains confident in its data, which demonstrates 94.1% accuracy and reliable sample matrix alignment to blood. The company is actively preparing for its planned U.S. launch in 2025, while its full panel test is already adopted in 19 countries with over 400 accounts globally.
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