Tresmonet Technologies, Inc., TM Testing, Inc. dba TM Technologies, Inc./TM Labs Warning Letter Details

Summary

Tresmonet Technologies and TM Testing sold COVID-19 rapid antibody test kits directly to consumers for at-home use without FDA approval, clearance, or authorization, rendering the product adulterated under section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act. The company failed to obtain required premarket approval (PMA), investigational device exemption (IDE), or 510(k) clearance before marketing the device, and did not notify FDA of its intent to introduce the device into commercial distribution as required by section 510(k). The violation was identified during FDA website reviews conducted in August 2020 and March 2021.