Mitsubishi Chemical Medience, a member of the Mitsubishi Chemical Holdings, has received the US Food and Drug Administration (FDA) 510(k) approval for its PATHFAST cTnI-II (cardiac Troponin I) diagnostic test.
PATHFAST cTnI-II test is designed to be used with the PATHFAST analysis system, a chemi-luminescence immunoanalyzer that measures concentrations of emergency biomarkers from a single whole blood sample.
PATHFAST system whole blood use capability eliminates the need for centrifugation of the specimen preparation, and can be used with either plasma or serum.
The test determines the quantity of cardiac troponin I and due to its coronary specificity, cardiac troponin I is considered the biomarker for diagnosing cardiac muscle damage, particularly following a heart attack.
The 510(k) clearance of the PATHFAST cTnI-II test completes the cardiovascular product line of the PATHFAST analysis system, which also includes tests to determine quantities of N-terminal pro brain natriuretic peptide (NT-proBNP), D-Dimer, myoglobin, creatinine kinase (CK)-MB and high-sensitivity C-reactive protein (hsCRP).
It is useful in the emergency room (ER) setting, as well as in satellite laboratories, physician laboratories, and central laboratories.