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ProDx Health was warned for offering HIV serological diagnostic self-collection kits for sale in the United States without required FDA marketing authorization. The company's kits violated federal law by lacking either an approved Premarket Approval (PMA) application or an Investigational Device Exemption (IDE), rendering them adulterated devices, and by failing to provide the required section 510(k) notification before commercial distribution, making them misbranded. The FDA determined that the self-collection kits, which allowed individuals to collect samples at home and ship them to laboratories for HIV testing, had never been authorized for this intended use.