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 QuidelOrtho Corporation (QuidelOrtho), a global leader of in vitro diagnostics, announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for its 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).
"Cardiovascular care depends on speed, accuracy and confidence," said Jonathan Siegrist, PhD, executive vice president of research & development & chief technology officer. "With FDA clearance of our VITROS hs Troponin I Assay, clinicians using VITROS Systems can access high-sensitivity cardiac troponin testing that fits seamlessly into existing workflows and supports timely, guideline-aligned decision-making in emergency and acute settings."
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 Siegrist.
The commercial rollout for US laboratories operating VITROS Systems will begin later this year. For ordering information, validation support or technical documentation, customers should contact their QuidelOrtho representative.
With expertise spanning clinical chemistry, immunoassay, immunohematology and molecular testing, QuidelOrtho Corporation is a leading global provider of diagnostic solutions, delivering fast, accurate and reliable results that help improve patient outcomes – from the point of care to hospital, lab to clinic. Building on a legacy of innovation, QuidelOrtho works with healthcare providers to advance diagnostics that connect insights with solutions, defining a clearer path for informed decisions and better care.
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