FDA Clears Siemens Healthineers' Xprecia Stride Coagulation Analyzer
By Jof Enriquez,
Follow me on Twitter @jofenriq
The U.S. Food and Drug Administration (FDA) has issued 510(k) clearance for the Xprecia Stride Coagulation Analyzer, a handheld device developed by Siemens Healthineers for reliable monitoring of oral anticoagulation therapy with warfarin, a vitamin K antagonist.
No bigger than a smartphone and weighing just 10.5 oz., the device collects fresh capillary (fingerstick) whole blood samples to generate Prothrombin Time International Normalized Ratio (PT/INR) lab values. The PT/INR test is a common test to monitor the effectiveness of the anticoagulant warfarin, which inhibits the formation of clots in people at high risk of developing them, such as those with atrial fibrillation, heart valve replacement surgery, deep vein thrombosis, pulmonary embolism, antiphospholipid syndrome, and congenital heart defects.
Xprecia's small form factor makes it ideal for point-of-care monitoring by health care providers in clinics and outpatient settings, according to Siemens' healthcare division. The device features an intuitive user interface with simple icons in a colored and animated display, as well as an integrated barcode scanner for easy data capture and smooth patient workflow. It also has a first-of-its kind test strip eject button that allows the user to eject a used test strip for safe disposal.
"Among the many challenges of point of care testing, accuracy and safety have become paramount to both the user and patient. With the Xprecia Stride analyzer, Siemens Healthineers delivers on the promise to bring a safe and lab-accurate test directly to the patient,” said Michael Sampson, SVP, Point of Care, Siemens Healthineers, North America, in a news release. “The Xprecia Stride analyzer is designed to be safe, efficient and ergonomically friendly. By adding the Xprecia Stride analyzer to our existing product portfolio in the U.S., we now have the ability to cover the full range of hemostasis testing from the hospital lab to the physician’s office.”
Like Siemens Healthineers central lab analyzers, the Xprecia Stride Coagulation Analyzer uses the Dade Innovin reagent to limit variability in generating INR results, making it as reliable as hospitals and large labs that run fully-automated coagulation analyzers, including those powered by Siemens Healthineers' newly unveiled Atellica Solution.
Siemens reported in August that Healthineers is becoming a very strong and growing business since its rebranding in May. It recently expanded into molecular cancer diagnostics and hospital IT solutions. Also, the company is leveraging its more than 30 years of central lab hemostasis experience to develop portable products such as the Xprecia Stride Coagulation Analyzer, as point of care testing becomes more commonplace in the age of precision medicine.