FDA clears first point-of-care allergy test device

The Food and Drug Administration (FDA) granted clearance to market the first point-of-care device to diagnose allergies in the offices with a moderate-complexity lab.

Uppsala, Sweden-based Phadia earned the clearance to sell its ImmunoCAP Rapid System. With the system, physicians who treat patients who have asthma and rhinitis will have semi-quantitative measurements of IgE levels for 10 common inhalant allergens in the United States in about 20 minutes, according to the company.

Retail prices for the ImmunoCAP Rapid System, which has been used in Europe for three years, were not available.