FDA cites LumiQuick Diagnostics for marketing Dx tools without approval

The FDA is citing LumiQuick Diagnostics for allegedly marketing diagnostic devices without premarketing approval. Specifically, regulators accused the California company in a July 31, 2013, warning letter of skirting the PMA application process for its QuickView test cards, which are designed to spot markers for prostate cancer, infectious diseases such as syphilis and rotavirus, and cardiac abnormalities. Regulators also cited the company for medical device reporting violations: for lacking procedures designed to govern how the company reports any product removals or correct how it complies with FDA regulations. The FDA inspected the company's Santa Clara operations from November 26 through December 7, 2012.  Warning letter

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