Enhancing cardiac care: FDA clearance for QuidelOrtho’s VITROS hs Troponin I Assay

The U.S. Food and Drug Administration (FDA) has granted QuidelOrtho 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. The commercial rollout for U.S. laboratories operating VITROS Systems will begin later this year.

Why this clearance matters: 

• Heart disease is the leading cause of death for men and women aged 45 and over, and for most racial and ethnic groups in the U.S. 
• Every 34 seconds, someone in the U.S. dies from cardiovascular disease. 
• In 2023, 919,032 people in the U.S. died from cardiovascular disease, about 1 in every 3 deaths. 
• High-sensitivity troponin assays can save more lives by identifying patients having a heart attack earlier, allowing faster rule out of low-risk patients and improving clinical outcomes for both patient groups. Studies show that implementing an hs troponin pathway can reduce 30-day mortality by 12% and 1-year mortality by 10% in patients with suspected acute coronary syndrome (“ACS”). High-sensitivity troponin tests consistently improve the accuracy and efficiency of identifying ACS patients for better patient care and outcomes. 

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