QuidelOrtho Announces FDA Clearance For VITROS Hs Troponin I Assay

(RTTNews) - QuidelOrtho (QDEL) announced the FDA has granted 510(k) clearance for the VITROS hs Troponin I Reagent Pack. The assay is intended for the quantitative measurement of cardiac troponin I in human plasma to aid in the diagnosis of myocardial infarction. The commercial rollout for U.S. laboratories operating VITROS Systems will begin later in the current year.

Jonathan Siegrist, Executive Vice President of Research & Development & Chief Technology Officer, said: "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."

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