510(k) approval for Dade-Behring's PFA 100 platelet function analyser:
This article was originally published in Clinica
Executive Summary
Dade-Behring's PFA-100 platelet function analyser has received 510(k) approval from the FDA. Intended for clinical use, the system measures the efficacy of the patient's platelets in forming a "plug" during the first phase of blood-clot formation. It also simulates the physiological processes of platelet activation, adhesion and aggregation occurring in a damaged blood vessel. Only a very small blood sample of 800 microlitres is required and the test can be run from an existing sample.