November 3, 2025- The U.S. Food and Drug Administration (“FDA”) has granted QuidelOrtho Corporation 510(k) clearance for the VITROS hs Troponin I Reagent Pack (the “VITROS hs Troponin I Assay”). The assay is intended for the quantitative measurement of cardiac troponin I (cTnI) in human plasma (heparin) to aid in the diagnosis of myocardial infarction (MI).
The VITROS Systems are built on dry-slide, MicroWell and INTELLICHECK™ Technologies designed to deliver workflow efficiency, reliability and quality clinical results in laboratories worldwide. To learn more about VITROS Systems, visit: VITROS Systems | QuidelOrtho.
The commercial rollout for U.S. laboratories operating VITROS Systems will begin later this year.