Lusys Laboratories, Inc. Warning Letter Details

Summary

Lusys Laboratories manufactured and distributed COVID-19 IgG/IgM Antibody Tests and COVID-19 Viral Antigen Tests without obtaining required FDA marketing approval, clearance, or authorization, making the products adulterated under section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act. The company failed to submit a premarket approval (PMA) application, investigational device exemption (IDE), or the required section 510(k) notification before introducing these devices into U.S. commercial distribution, resulting in misbranding violations under section 502(o) of the Act. An FDA inspection conducted in September 2021 identified these violations, and the agency prohibited further introduction or delivery of these unapproved products into interstate commerce.