Technology | Point of Care Testing | November 10, 2016

Siemens Receives FDA Clearance of Xprecia Stride Coagulation Analyzer

Handheld portable PT/INR analyzer designed for any professional point-of-care setting

Siemens, FDA clearance, Xprecia Stride Coagulation Analyzer, point-of-care testing

November 10, 2016 — Siemens Healthineers announced U.S. Food and Drug Administration (FDA) 510(k) clearance for a hand-held portable coagulation analyzer. The Xprecia Stride Coagulation Analyzer delivers fast, reliable Prothrombin Time/International Normalized Ratio (PT/INR) testing for point-of-care monitoring and management of oral anticoagulation therapy with warfarin, a vitamin K antagonist.

Millions of PT/INR tests are administered worldwide each year as part of therapy monitoring for patients with a host of conditions, including atrial fibrillation, heart valve replacement surgery, deep vein thrombosis and congenital heart defects, among others. The Xprecia Stride Coagulation Analyzer was specifically designed to meet the growing demand for fast and reliable PT/INR results in physician offices and walk-in clinics to help healthcare professionals make informed decisions about patient care.

No bigger than a smartphone and weighing just 10.5 oz, the Xprecia Stride Coagulation Analyzer can be held at virtually any angle and brought directly to the patient’s finger for efficient and comfortable blood sample application.

The device sports an intuitive user interface and features such as an integrated barcode scanner to simplify data capture and improve patient workflow. To further enhance usability, it features simple icons and animation in a color display more commonly found in mobile devices than medical instruments.

The Xprecia Stride analyzer uses fresh capillary (fingerstick) whole blood and results are expressed as INR. It utilizes the same Dade Innovin reagent used by Siemens Healthineers central lab analyzers to minimize any potential for variability. Studies have shown the performance to be equivalent to a reference laboratory hemostasis system,1 with results available within minutes.

Safety features include a first-of-its kind test strip eject button that allows the user to eject a used test strip and easily dispose of it without touching it, minimizing potential biohazard exposure.

When taken together, all of these innovations ultimately enable better patient care as point-of-care PT/INR testing becomes critical to healthcare providers managing the growing number of patients that require anticoagulation therapy.

For more information: www.siemens.com

¹ White Paper, Fernando R, Jacobson AK, Kennedy S, Lessard C, Olson K, Scribner A, “PT/INR Test Performance of the Xprecia Stride Coagulation Analyzer Demonstrates Equivalency with Established Laboratory Hemostasis and Point-of-care Methods”

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