NEW YORK (GenomeWeb News) – The US Food and Drug Administration this week gave 510(k) clearance to Beckman Coulter's Access AccuTnl+3 troponin l assay for use on the company's Access 2 immunoassay system.

In order to gain the long-awaited clearance, Beckman Coulter conducted a prospective clinical trial for the assay that included the enrollment of more than 1,900 subjects, following guidance from FDA in 2010 that manufacturers of troponin assays modernize the performance evaluation and regulatory review of such tests, the company said.

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