FDA WARNING_LETTER - ikcon investments, inc - February 11, 2021

On March 25, 2021, the FDA issued a Warning Letter to a firm operating websites www.ikconmedical.com and www.akcutestshop.com, following reviews on February 3, 4, and 11, 2021. The FDA found the firm was selling "Akcutest COVID-19 Antibody Test" and "Lumigenik COVID-19 Antigen Rapid Test" products, intended for COVID-19 mitigation, prevention, treatment, diagnosis, or cure.

These products are deemed devices under section 201(h) of the Act, 21 U.S.C. § 321(h). They are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because the firm lacks required premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), for failure to notify the FDA of intent to commercially distribute, as required by section 510(k).

Additionally, the "Akcutest Kit" is misbranded under section 502(a) of the Act, 21 U.S.