Mitsubishi Chemical Medience Receives 510(k) Clearance for Pathfast Cardiac Troponin I Test in U.S.

 

June 17, 2011
The Pathfast cTnI-II (cardiac troponin I) test from Mitsubishi Chemical Medience Corporation was granted 510(k) premarketing notification clearance by the U.S. Food and Drug Administration (FDA), clearing it for sale in the United States. It is designed for use with the Pathfast analysis system, a self-contained, bench-top chemi-luminescence immunoanalyzer that measures concentrations of emergency biomarkers from a single whole blood sample.

The test determines the quantity of cardiac troponin I, a protein that is integral to cardiac muscle contraction, which is elevated in the bloodstream after damage to the myocardium (the middle and thickest layer of the heart wall). Due to its absolute coronary specificity and high sensitivity, cardiac troponin I is the preferred biomarker for diagnosing cardiac muscle damage, particularly following a heart attack.

The 510(k) clearance of the 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). With its whole blood use capability, the system eliminates the need for centrifugation of the specimen preparation, and can be used with either plasma or serum. The system has a 17-minute turnaround time, a feature that can significantly reduce testing time, a key consideration in a clinical laboratory or point-of-care (POC) setting.

The Pathfast cTnI-II test is considered “guideline acceptable” by virtue of its minimal imprecision, as measured by a coefficient of variance (CV) of less than or equal to 10 percent at the 99th percentile. It is expected to enhance patient safety by streamlining coordination between emergency POC and central laboratories. It may be particularly useful in the emergency room (ER) setting, as well as in satellite laboratories, physician laboratories, and central laboratories.