Test Aids in Identifying and Containing Norovirus Outbreaks

The FDA reviewed data for Ridascreen via the de novo pathway, an alternative path to market for devices that are lower risk and may not require premarket approval (PMA), but are of a new type, and therefore may not be able to be cleared in a "510(k)" premarket notification.

"This test provides an avenue for early identification of Norovirus," said Jeffrey Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health. "Early intervention can halt the spread of an outbreak."

Norovirus is a leading cause of food-borne disease outbreaks in the United States. Contamination usually occurs in settings where there is close group contact, such as cruise ships, hospitals, long-term care facilities, and schools or child-care centers. It is a highly contagious virus that spreads rapidly through direct person-to-person contact, contaminated food, or water, or by touching contaminated surfaces.

The test is not sensitive enough for use when only a single person has symptoms and should not be used for diagnosing individual patients.

Ridascreen is made by R-Biopharm AG (Darmstadt, Germany).

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R-Biopharm AG

US Food and Drug Administration