FDA gives 510(k) approval for ADEXUSDx hCG test for pregnancy-NOWDiagnostics

NOWDiagnostics' ADEXUSDx hCG point-of-care test, which uses only a single drop of capillary or whole blood to quickly and accurately diagnose pregnancy earlier than urine-based tests, has now been CLIA registered and classified by the FDA. The new hCG test is the first single-step, capillary blood hCG test requiring no equipment to receive FDA 510(k) clearance.

The test is an immunoassay used for the qualitative detection of human chorionic gonadotropin in human whole blood, plasma, or serum and is indicated as an aid for health care professionals in the diagnosis of early pregnancy. Pregnancy tests are based on the detection of human chorionic gonadotropin (hCG), a hormone produced by the placenta around the fourth day after conception. hCG levels rise rapidly and double approximately every two days. The ADEXUSDx hCG Test can detect hCG in a single drop of whole blood, serum, or plasma without additional reagents or materials. The ADEXUSDx hCG Test is a rapid chromatographic immunoassay that delivers results in ten minutes.