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FDA Clears Quidel Drug Screen, Toxicology Test

NEW YORK (360Dx) – Quidel said on Tuesday that the US Food and Drug Administration has granted 510(k) clearance for its fluorescence immunoassay test, the Triage TOX Drug Screen, 94600, which simultaneously detects different drug metabolites in urine.

The test, cleared for use with Quidel's Triage MeterPro instrument, uses monoclonal antibodies that are specific for the metabolites of nine drug classes, Quidel said.

The speed and sensitivity of immunoassays have made them "the most accepted method for screening urine for the presence of drugs," the firm noted in a statement.

Douglas Bryant, president and CEO of San Diego, California-based Quidel, said that its diagnostic screening test "can play an important role in providing fast diagnostic answers to healthcare providers in the emergency and urgent-care settings."

Results are displayed on the firm's Triage MeterPro screen about 15 minutes after the addition of a specimen, and the meter can transmit results to the laboratory or hospital information system.