Loading…
Ikcon Investments, Inc dba Ikcon Medical was cited for selling unapproved COVID-19 diagnostic test kits—the Akcutest COVID-19 Antibody Test and Lumigenik COVID-19 Antigen Rapid Test—through their websites without FDA marketing approval, clearance, or authorization. The products were found to be adulterated under federal law because the company lacked an approved premarket approval (PMA) application or investigational device exemption (IDE), and were misbranded under section 502(o) of the Federal Food, Drug, and Cosmetic Act. The enforcement action occurred during the height of the COVID-19 pandemic, reflecting FDA's focus on preventing unauthorized and potentially unreliable diagnostic devices from entering the market.