Blackfly Investments, LLC dba Molecular® Testing Labs

Warning LetterOpen

Adam Blackwell Co-Founder and Head of New Product Development and Laboratory Production Blackfly Investments, LLC dba Molecular® Testing Labs 14401 SE 1st Street Vancouver , WA 98684 United States info@moleculartestinglabs.com adam@moleculartestinglabs.comIssued Oct 11, 2024Center for Biologics Evaluation and Research (CBER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Letter Details

Firm: Blackfly Investments, LLC dba Molecular® Testing Labs
Location: Adam Blackwell Co-Founder and Head of New Product Development and Laboratory Production Blackfly Investments, LLC dba Molecular® Testing Labs 14401 SE 1st Street Vancouver , WA 98684 United States info@moleculartestinglabs.com adam@moleculartestinglabs.com
FEI Number: N/A
Country: United States
Issue Date: October 11, 2024
Issuing Office: Center for Biologics Evaluation and Research (CBER)
Product Type: Medical Devices
Status: Open

Summary

Blackfly Investments, LLC dba Molecular® Testing Labs was warned for offering an HIV serological diagnostic dried blood spot (DBS) card self-collection kit for sale in the United States without required marketing authorization. The company's product violated the Federal Food, Drug, and Cosmetic Act by lacking either an approved Premarket Approval (PMA) application or an approved Investigational Device Exemption (IDE), rendering the device adulterated and misbranded under FDA regulations. The FDA identified these violations through review of the company's website, previous correspondence, and submitted materials, determining the kit was being distributed directly to individuals for self-collection of samples without proper regulatory clearance.

Blackfly Investments, LLC dba Molecular® Testing Labs FDA Warning Letter, October 11, 2024