Abbott Laboratories has submitted a 510(k) Premarket Notification with the US FDA seeking clearance of the Troponin-I ADV test for use on Abbott's widely used AxSYM automated immunoassay instrument system.
Abbott revealed this at the annual meeting of the American Association of Clinical Chemistry (AACC).
Troponin-I is a protein that is released from dead or severely injured heart muscle cells following a cardiac event. Following appropriate regulatory approvals, Troponin-I ADV would replace the existing AxSYM Troponin-I assay in the United States and other major markets throughout the world.
"This test submission not only continues to show our commitment to enhancing the AxSYM menu but also the value we place on customer feedback. Troponin-I ADV was developed by working directly with our customers who helped evaluate and test the assay with the goal of improved stability and standardization," said William Brown, vice president, Diagnostic Assays and Systems Development, Abbott Laboratories.
Part of an acute cardiac diagnostic menu, doctors consider troponin assays to be one of the most important tests to use when diagnosing heart attacks. The current AxSYM Troponin-I assay was first introduced during the mid-90s.
The AxSYM immunoassay system can process up to 80 to 120 tests per hour allowing medium-volume clinical laboratories to process a variety of immunodiagnostic tests simultaneously. Test menus include assays for abused drugs, cancer, cardiac, endocrinology, fertility, hepatitis, infectious disease, metabolic/renal, therapeutic drug monitoring and toxicology.