In Brief: Dade Behring PFA-100
This article was originally published in The Gray Sheet
Executive Summary
Dade Behring PFA-100: Firm receives FDA 510(k) clearance of its microprocessor-based, blood-platelet analyzer and disposable test cartridges for use in clinical labs to measure the ability of blood to clot during the first phase of hemostasis. The system requires an 800-microliter blood sample (about 16 drops) and delivers quantitative results in five to 10 minutes. Information obtained from the test "is particularly important for treating patients with abnormal bleeding caused by medication such as aspirin...or due to congenital conditions such as von Willebrand disease," the firm claims. Available in Europe since 1996, the test will complement other hemostasis products marketed by Dade Behring that measure the blood's clotting ability in the second phase of hemostasis...