Intelligent Bio Solutions Inc. announced the submission of its Additional Information (AI) response to the U.S. Food and Drug Administration (FDA) as part of its ongoing 510(k) clearance process. This response includes new positive data that strengthens the company’s submission and further validates the security and performance of its fingerprint sweat-based drug screening technology.
The updated submission incorporates data from intensive cybersecurity testing, including penetration and electromagnetic compatibility testing, reinforcing the system’s resilience across varied environments. An extraordinary 10,000 hours were dedicated to collecting new data, resulting in 23 detailed test reports and over 100 supporting attachments, totaling over 1900 pages.
INBS also reaffirmed the accuracy of its technology using advanced quantification methods, including human eccrine sweat testing with an Ultra-Micro Balance scale. The company expects a response from the FDA within six weeks, as it continues to advance its U.S. expansion strategy for its opiate test system for codeine.
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