FDA clears Beckman's 12-minute cardiac test:
This article was originally published in Clinica
Beckman Coulter has received US FDA 510(k) clearance to market its 12-minute, troponin I test for helping to diagnose heart attack and cardiac muscle damage. The Access AccuTnI test is run on the Beckman's Access immunoassay system and is intended for use by hospitals in routine and emergency situations. It is one of the fastest cardiac tests on the market, claims the Fullerton, California company. The new test is one of 36 available on the Access platform.