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Beckman Coulter obtains FDA 510(k) approval for cardiac disease management assay

Beckman Coulter, a manufacturer of biomedical laboratory instruments, has obtained the 510(k) approval from the US Food and Drug Administration (FDA) for its Access AccuTnI+3 troponin I assay for use on the UniCel DxI series of immunoassay systems.

The Access AccuTnI+3 troponin I assay delivers precision, clinical sensitivity and clinical specificity necessary to assist physicians with the diagnosis of myocardial infarction.

In June 2013, Beckman Coulter received an approval for the Access AccuTnI+3 troponin I assay for use on the company’s Access 2 immunoassay analyzer.

With this new 510(k) approval, the assay can now be used on all of the company’s immunoassay systems, as well as the UniCel DxC integrated chemistry and immunoassay series.

Beckman Coulter Diagnostics president Arnd Kaldowski noted the AccuTnI+3 troponin assay has been clinically proven through a large multi-center study that enrolled more than 1,900 subjects, and it is confirmed that the test provides the clinical performance needed for optimal patient management.

"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," Kaldowski added.