Biosite Diagnostics' cardiac panel gets green light:
This article was originally published in Clinica
The FDA has given a 510(k) marketing clearance to Biosite Diagnostics' Triage Cardiac Panel. The panel provides rapid simultaneous quantitative measurement of three important biochemical markers for heart attacks and is used in conjunction with the Triage Meter. Prior to selling the cardiac panel, the company will be required to obtain clearance for two additional 510(k)'s, related to test quality control and calibration, and another for the Triage Meter.