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Empowered Diagnostics LLC distributed unapproved COVID-19 diagnostic test kits (CovClear COVID-19 Rapid Antigen Tests and ImmunoPass COVID-19 Neutralizing Antibody Rapid Tests) without required FDA marketing authorization, making the products adulterated under section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act. The company failed to obtain premarket approval (PMA) or investigational device exemption (IDE) authorization and did not submit the required section 510(k) notification, resulting in misbranding violations under section 502(o) of the Act. The FDA inspection conducted in February 2022 identified these violations and prohibited further introduction or delivery of the products into interstate commerce.