Troponin IVDs

Intended purpose

The i-STAT High Sensitivity Troponin-I (i-STAT hs-TnI) test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I (cTnI) in whole blood or plasma samples using the i-STAT System in point of care or clinical laboratory settings. The i-STAT hs-TnI test is intended to be used as an aid in the diagnosis of myocardial infarction (MI). The i-STAT High Sensitivity Troponin I (i-STAT hs-TnI) controls are used to monitor the performance of the i-STAT hs-TnI test. The i-STAT High Sensitivity Troponin I (i-STAT hs-TnI) Calibration Verification Materials are used to verify the calibration of the i-STAT hs-TnI test throughout the reportable range.