In Brief: Biosite Diagnostics
This article was originally published in The Gray Sheet
Executive Summary
Biosite Diagnostics: Triage point-of-care panel for CK-MB, myoglobin and troponin I measurement gains 510(k) clearance to be used in conjunction with the Triage meter for myocardial infarction detection. Biosite awaits pending 510(k) clearances for test quality control/calibration and Triage meter products before launching the Triage panel. The 15-minute test consists of a small, single-use cartridge utilizing capillary technology to control blood flow through zones containing immobilized antibodies to the three biochemical markers, which are quantitatively measured by the Triage Meter. Data from a four-center, 800-patient study show "sensitivity and specificity of the Triage cardiac panel was substantially equivalent to commercially available analyzer-based assays," the firm claims...