Beckman Coulter Inc, Brea, Calif, has received FDA 510(k) clearance for its new Access AccuTnI+3 troponin I assay for use on the UniCel DxI series of immunoassay systems.
The new assay delivers the precision, clinical sensitivity, and clinical specificity necessary to assist physicians with the diagnosis of myocardial infarction.
“The AccuTnI+3 troponin assay has been clinically proven through a large multicenter study that enrolled more than 1,900 subjects, and it is confirmed that the test provides the clinical performance needed for optimal patient management,” says , president, Beckman Coulter Diagnostics. “Our new troponin I assay is directly aligned with the FDA’s October 2010 guidance to manufacturers of troponin assays and confirms our commitment to modernize the performance evaluation of this critical test.”
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.
[Source: Beckman Coulter]