FDA WARNING_LETTER - KBMO Diagnostics, LLC - June 16, 2020

On June 17, 2020, the FDA issued a Warning Letter to KBMO Diagnostics after reviewing their website, www.kbmodiagnostics.com, on June 16, 2020. The letter addresses the firm's "COVID-19 Fingerstick Test Kit," an at-home sample collection kit for COVID-19 serology testing.

The FDA determined this product is a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the "Act") because it is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.

The product is deemed adulterated under section 501(f)(1)(B) of the Act as KBMO Diagnostics lacks an approved premarket approval (PMA) or investigational device exemption (IDE) application. It is also misbranded under section 502(o) of the Act for failure to notify the FDA of intent to introduce the device into commercial distribution (510(k) requirement). Furthermore, the product is misbranded under section 502(a) due to unauthorized use of the FDA logo on their webpage, which implies FDA endorsement.

The FDA requests immediate action to cease the sale of this unapproved, uncleared, and unauthorized product. KBMO Diagnostics must email COVID-19-Task-Force-CDRH@fda.