FDA WARNING_LETTER - Amplicon Land, LLC - May 17, 2021

On June 7, 2021, the FDA issued a Warning Letter to AmpliconExpress/Amplicondist regarding the sale of the "QuikPacII COVID-19 IgG/IgM Test" on their websites, http://ampliconexpress.com and http://amplicondist.com, observed on May 17, 2021. The FDA determined the COVID-19 Test Kit is a device under section 201(h) of the Act, intended for COVID-19 mitigation, prevention, treatment, diagnosis, or cure.

The product is deemed adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o) of the Act as the firm failed to notify the FDA of its intent to introduce the device into commercial distribution, violating section 510(k). The introduction or delivery of this product into interstate commerce is prohibited under section 301(a) and 301(k) of the Act.

The FDA requested immediate action to cease sales of the unapproved, uncleared, and unauthorized COVID-19 products. The firm must email COVID-19-Task-Force-CDRH@fda.hhs.gov within 48 hours, detailing corrective