Beckman Coulter, a subsidiary of Danaher Corporation, has received 510(k) approval from the US Food and Drug Administration (FDA) for its new Access AccuTnI+3 troponin I assay for use in its Access 2 immunoassay system.
In October 2010, the FDA issued guidance to manufacturers of troponin assays as part of its efforts to modernize the performance evaluation and regulatory review of these critical tests.
The FDA requested that manufacturers carry out a clinical study in order to modernize the labeling and claims to ensure that laboratories and clinicians are informed of the actual performance of troponin assays to help in result interpretation and laboratory verification of performance parameters.
In line with these requirements, Beckman Coulter conducted a large multicenter prospective clinical trial on the AccuTnI+3 troponin I assay trial, for which it enrolled over 1,900 subjects. Following the completion of the trial, the company confirmed that the assay provides the clinical performance needed for optimal patient management.
The data from this trial reveals that the assay delivers the precision, clinical sensitivity and clinical specificity necessary to assist physicians with the diagnosis of MI, the company claimed.
Beckman Coulter president Arnd Kaldowski said that the clinicians have depended on the company’s troponin I test for over 12 years and the new AccuTnI+3 assay has the proven performance to continue providing dependability to laboratories supporting emergency care.
"Our new troponin I assay offers emergency physicians confidence in results that enable them to provide excellent care for patients at risk of MI," Kaldowski added.