FDA WARNING_LETTER - tresmonet technologies, inc., tm testing, inc. - April 15, 2021

The FDA issued a Warning Letter to TM Test Kits on March 24, 2021, following website reviews on August 19, 2020, and March 17, 2021. The company's "COVID-19 IgM/IgG Rapid Test" is offered for direct sale to consumers for at-home testing, intended for COVID-19 mitigation, prevention, treatment, diagnosis, or cure.

The product is deemed adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because it lacks FDA premarket approval (PMA) or an investigational device exemption (IDE). It is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), as the firm failed to notify the FDA of its intent to introduce the device into commercial distribution, as required by section 510(k). Furthermore, the product is misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), due to misleading "FDA-approved" claims on the website.

The FDA has not approved, cleared, or authorized any COVID-19 serology test for at-home use due