QuidelOrtho announces FDA 510(K) clearance of hs Troponin Assay
Clearance expands menu and enables high-sensitivity troponin I measurement to aid in the diagnosis of myocardial infarction
17 Nov 2025Industry news
The U.S. Food and Drug Administration (FDA) has granted QuidelOrtho Corporation 510(k) clearance for the VITROS™ hs Troponin I Reagent Pack. 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.
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.
“Behind every test result is a person and a family. As part of our ongoing commitment to our clinically impactful cardiac menu, our VITROS hs Troponin I Assay can help clinicians evaluate suspected heart attacks with speed and confidence. With this FDA clearance, laboratories running VITROS Systems can bring that capability to more patients consistently, when minutes matter,” said Jonathan Siegrist, PhD, Executive Vice President of Research & Development & Chief Technology Officer.
The commercial rollout for U.S. laboratories operating VITROS Systems will begin later this year. For ordering information, validation support or technical documentation, customers should contact their QuidelOrtho representative.