FDA WARNING_LETTER - Blackfly Investments, LLC dba Molecular? Testing Labs - October 11, 2024

On October 11, 2024, the FDA issued a Warning Letter to Blackfly Investments, LLC dba Molecular Testing Labs (MTL) for offering an HIV serological diagnostic dried blood spot (DBS) card self-collection kit without marketing authorization. The FDA determined the kit is a device under section 201(h)(1) of the FD&C Act.

The HIV DBS card self-collection kit is deemed adulterated under section 501(f)(1)(B) of the FD&C Act because it lacks an approved premarket approval application (PMA) or an approved investigational device exemption (IDE). It is also misbranded under section 502(o) of the FD&C Act due to the absence of a required 510(k) notification.

Despite prior communications and FDA recommendations to submit a De Novo request for marketing authorization, MTL has not done so. The FDA has not authorized the kit for any use, including HIV serological diagnostic testing. MTL's website continues to market the device, and the firm's January 18, 2024, response did not indicate discontinuation of the kit.

The FDA emphasizes the critical need to evaluate the kit's safety and effectiveness, including reliable sample collection and transport conditions. The FDA requests MTL cease activities resulting in misbranding or adulteration of the kit and provide a written response within fifteen working days detailing