Beckman Coulter, Inc., has announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its new Access AccuTnI+3 troponin I assay for use on its Access 2 immunoassay system. Says Arnd Kaldowski, president, Beckman Coulter Diagnostics: “The new troponin I assay offers emergency physicians confidence in results that enable them to provide excellent care for patients at risk of myocardial infarction (MI).”
In October 2010, the FDA issued guidance to all manufacturers of troponin assays in an effort to modernize the performance evaluation and regulatory review of these critical tests. The FDA requested that manufacturers conduct a clinical study to “modernize the labeling and claims in order to ensure that laboratories and clinicians are informed of the true performance of troponin assays to help in result interpretation and laboratory verification of performance parameters.”
In accordance with the FDA’s new requirements, Beckman Coulter conducted a large multicenter prospective clinical trial on the AccuTnI+3 troponin I assay. The trial enrolled more than 1,900 subjects, and it confirmed that the assay provides the clinical performance needed for optimal patient management. The data from this trial showed that the assay delivers the precision, clinical sensitivity, and clinical specificity necessary to assist physicians with the diagnosis of MI. Read more about the assay.
