BioCentury
ARTICLE | Clinical News

Access AccuTnl+3 troponin I assay regulatory update

October 7, 2013 7:00 AM UTC

Danaher's Beckman Coulter Inc. subsidiary said FDA granted 510(k) clearance for its Access AccuTnl+3 troponin I assay for use on its UniCel DxI series of immunoassay systems to determine levels of cardiac troponin I in human serum and plasma. The assay, which was cleared for use on Beckman's Access 2 immunoassay system in June, is now available on all of the company's immunoassay systems (see BioCentury, June 24). Beckman said the use of cardiac troponin I levels aids in the risk stratification of patients with unstable angina or non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction or increased probability of ischemic events requiring urgent revascularization procedures. ...