CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Beckman Coulter has received FDA 510(k) clearance for its Access AccuTnI+3 troponin I assay for use on its Access 2 immunoassay system.
In accordance with FDA requirements, the company conducted a large multicenter prospective clinical trial on the AccuTnI+3 troponin I assay that enrolled more than 1,900 subjects, and confirmed that the assay provides the clinical performance necessary for optimal patient management.
The data from this trial show that Beckman Coulter’s Access AccuTnI+3 troponin I assay provides the precision, clinical sensitivity, and clinical specificity necessary to assist physicians with the diagnosis of myocardial infarction.
Beckman Coulter, 800-742-2345