FDAnews Device Daily Bulletin
Medical Devices / Commercial Operations

NOWDiagnostics Gets 510(k) Approval for Blood Pregnancy Test

Aug. 14, 2015
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NOWDiagnostics has received 510(k) clearance from the FDA for its ADEXUSDx blood test, which accurately diagnoses pregnancies two to eight days earlier than urine-based tests.

A single drop of capillary or whole blood is needed to perform the testing, providing results in just 10 minutes, the Springdale, Ark., company says.

NOWDiagnostics is offering the pregnancy tests in the U.S. and Europe. The company also markets two cardiac and three toxicology tests in Europe.

Future plans include the development of tests for sexually transmitted diseases, food intolerances and common infectious diseases, the devicemaker says. — John Bechtel