ProDx Health

Warning LetterOpen

Andreas Kogelnik, MD, PhD Founder & Chief Executive Officer ProDx Health 1190 O'Brien Dr Menlo Park , CA 94025 United States support@prodxhealth.comIssued Feb 10, 2026Center 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: ProDx Health
Location: Andreas Kogelnik, MD, PhD Founder & Chief Executive Officer ProDx Health 1190 O'Brien Dr Menlo Park , CA 94025 United States support@prodxhealth.com
FEI Number: N/A
Country: United States
Issue Date: February 10, 2026
Issuing Office: Center for Biologics Evaluation and Research (CBER)
Product Type: Medical Devices
Status: Open

Summary

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.