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NOWDiagnostics obtains FDA 510(k) approval for ADEXUSDx test

NOWDiagnostics has received 510(k) approval from the US Food and Drug Administration (FDA) for its ADEXUSDx hCG point-of-care test, which allows health care professionals in an early detection of pregnancy in different clinical and critical care settings.


The ADEXUSDx test is said to use only a single drop of capillary or whole blood to rapidly and accurately diagnose pregnancy earlier than urine-based tests.

NOWDiagnostics president and CEO Kevin Clark said: "It’s too important for the safety of the mother and fetus to not have accurate pregnancy results in our emergency rooms and clinics.

"We see a great opportunity to save hospitals and clinics time, money and resources by providing them a lab in the palm of their hands."

The company has designed this new immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in human whole blood, plasma or serum.

It is claimed to detect pregnancy around two to eight days earlier than commonly available urine-based tests, based on the woman and her pregnancy.

According to the company, the test results are available ten minutes after the test is completed.

Currently, the firm is providing hCG (pregnancy) test in the US and Europe, as well as two cardiac (heart attack) tests and three toxicology tests in Europe.

Image: The ADEXUSDx hCG test will diagnose pregnancy earlier than urine-based tests. Photo: courtesy of PRNewswire/ NOWDiagnostics.