FDA Oks Beckman's AccuTnI+3 Troponin I Assay On UniCel DxI Immunoassay Systems

(RTTNews) - Delivering the precision, clinical sensitivity and clinical specificity necessary to assist physicians with the diagnosis of myocardial infarction or MI, Beckman Coulter, Inc. a subsidiary of Danaher Corp. (DHR) announced that it received the U.S. Food and Drug Administration or FDA clearance to its new Access AccuTnI+3 troponin I assay for use on the UniCel DxI series of immunoassay systems.

Following the June 2013 clearance of the Access AccuTnI+3 troponin I assay on Beckman Coulter's Access 2 immunoassay analyzer, the new troponin assay is now cleared for use on all of the company's immunoassay systems, as well as the UniCel DxC integrated chemistry and immunoassay series.

AccuTnI+3 delivers clinical sensitivity and specificity aligned with contemporary use of troponin set forth by the FDA and utilizes platform-specific reagents and calibrators, the company stated.