Intelligent Bio Solutions Inc. announced the successful collection of new data to further reinforce the security and performance of its Intelligent Fingerprinting Drug Screening System, strengthening its FDA 510(k) submission. The company plans to submit these findings to the FDA in August.
As part of this process, INBS completed rigorous cybersecurity testing, including penetration and electromagnetic compatibility testing, to validate the system’s resilience across varied operating environments. The company also reaffirmed the accuracy of its technology using advanced quantification methods, including human eccrine sweat testing with an Ultra-Micro Balance scale.
Peter Passaris, Vice President of Product Development, stated that 10,000 hours were dedicated to collecting new data, resulting in 23 detailed test reports and over 100 supporting attachments. This comprehensive effort aims to address FDA questions thoroughly and enhance the overall quality of the submission, which is critical for planned U.S. market entry.
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