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The PATHFAST® cTnl Calibrators are for calibration of the PATHFAST® system when used for the quantitative determination of cardiac Troponin I in human heparinized or EDTA whole blood and plasma.

The PATHFAST cTnl Calibrators are for calibration of the PATHFAST cTnl-II test performed on the PATHFAST instrument. PATHFAST cTnI-II test is an in vitro diagnostic test for the quantitative measurement of cardiac Troponin I (cTnl) in heparinized or EDTA whole blood and plasma. Measurements of cardiac Troponin I are used as an aid in the diagnosis of acute myocardial infarction. Currently, PATHAST cTnl Calibrators 1 and 2 are provided as lyophilized products of two vials each. Calibrator 1 consists of buffer only and Calibrator 2 consists of cTnI complex in buffer. Four vials of calibrator diluent also are provided for reconstitution of the calibrators. The diluent consists of an aqueous solution with 0.05% sodium azide. This Special 510(k) is being submitted for a change to a liquid Calibrator 1 formulation and a new dropper bottle container. There are no changes to PATHFAST cTnl Calibrator 2. As a result of elimination of the reconstitution step for PATHFAST cTnI Calibrator 1, the number of bottles of Calibrator Diluent is being reduced from four bottles to two bottles.

The PATHFAST® CK-MB-11 Calibrators are for calibration of the PATHFAST® system when used for the quantitative determination of creatine kinase-MB in human heparinized or EDTA whole blood and plasma.

The PATHFAST CK-MB-II Calibrators are used for calibration of the PATHFAST CK-MB-11 test performed on the PATHFAST instrument. PATHFAST CK-MB-II test is an in vitro diagnostic test for the quantitative measurement of creatine kinase-MB in heparinized or EDTA whole blood and plasma. Currently, PATHAST CK-MB-II Calibrators 1 and 2 are provided as lyophilized products of two vials each. Calibrator 1 consists of saline and a preservative, and Calibrator 2 consists of CK-MB in buffer. Four vials of calibrator diluent also are provided for reconstitution of the calibrators. The diluent consists of an aqueous solution with 0.05% sodium azide. This Special 510(k) is being submitted for a change to a liquid Calibrator 1 formulation and a new dropper bottle container. There are no changes to PATHFAST CK-MB-11 Calibrator 2. As a result of elimination of the reconstitution step for PATHFAST CK-MB-II Calibrator I, the number of bottles of Calibrator Diluent is being reduced from four bottles to two bottles.