Intelligent Bio Solutions submits Additional Information to FDA for 510(k) clearance.

Intelligent Bio Solutions has submitted an Additional Information response to the FDA as part of its 510(k) clearance process for its fingerprint sweat-based drug screening technology. The submission includes new positive data, intensive cybersecurity testing, and targeted updates to strengthen platform integrity and dependability. The Company plans to enter the US market later this year.

Intelligent Bio Solutions (Nasdaq: INBS) has submitted an Additional Information response to the FDA as part of its 510(k) clearance process for its fingerprint sweat-based drug screening technology. The submission includes new positive data, intensive cybersecurity testing, and targeted updates to strengthen platform integrity and dependability. The Company plans to enter the US market later this year.

The updated submission incorporates data from intensive cybersecurity testing, including penetration and electromagnetic compatibility testing, demonstrating the system's resilience across varied environments. An extraordinary 10,000 hours were dedicated to the collection of new data for the submission, which included 23 detailed test reports and more than 100 supporting attachments, totaling over 1900 pages, along with over 7800 lines of data collected throughout the process [1].

The accuracy of the technology has been reaffirmed using advanced quantification methods, including human eccrine sweat testing with an Ultra-Micro Balance scale. This ultra-sensitive measuring approach confirms the system's capability to detect and analyze minute sweat volumes found in a single fingerprint [1].

The FDA's expected response timeline of six weeks suggests the submission is comprehensive enough to facilitate a relatively prompt review. The Company appears well-positioned for its planned 2025 U.S. market entry, targeting clearance specifically for its opiate test system for codeine [1].

Intelligent Bio Solutions has been using its technology across 450 accounts in 24 countries, supporting workplace, law enforcement, and justice sectors. With 18 global distribution partners and growing awareness and adoption, the Company is steadily expanding its international presence. Entry into the multi-billion-dollar U.S. market will open significant opportunities for the Company as it pursues its global expansion plans [1].

References:
[1] https://www.stocktitan.net/news/INBS/intelligent-bio-solutions-strengthens-fda-510-k-package-with-new-oxybkpa7kpmk.html