Handheld Coagulation Analyzer Recieves FDA Clearance

For the first time, the US Food & Drug Administration (FDA) has given 510(k) clearance for a point-of-care (POC) Prothrombin Time / International Normalized Ratio (PT/INR) device based on the new rules published in March 2016. Winner of multiple design awards (e.g. Red Dot Award and iFDesign Award), the device includes a number of innovations and features not found on most other POC analyzers.

The handheld portable Xprecia Stride coagulation analyzer, from Siemens Healthineers (or Siemens Healthcare; Erlangen, Germany), delivers fast, reliable PT/INR testing for POC monitoring and management of oral anticoagulation therapy with the vitamin K antagonist warfarin. Results are available within minutes. Features promote safety, accuracy, and ease of use.

“Among the many challenges of POC 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, senior vice president, Point of Care, Siemens Healthineers, North America, “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 US, we now have the ability to cover the full range of hemostasis testing from the hospital lab to the physician’s office.”

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. Xprecia Stride was designed to meet the growing demand for 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, Xprecia Stride can be held at virtually any angle and brought directly to the patient’s finger for efficient and comfortable blood sample application. Only a small sample volume is required, obtained by fresh capillary (fingerstick) draw of whole blood. Results are expressed as INR.

Xprecia Stride utilizes the same Dade Innovin reagent used by Siemens Healthineers central lab analyzers to minimize potential for variability. Studies have shown the performance to be equivalent to a reference laboratory hemostasis system (White Paper available online).

To further address challenges, the Xprecia Stride analyzer was designed to provide intuitive user interface and features such as an integrated barcode scanner (enters lot calibration information and operator and patient IDs) to simplify data capture and improve patient workflow. Data such as patient and QC results can be transferred via USB port. Xprecia Stride uses simple icons and animation in a color display more commonly found in mobile devices than medical instruments.

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

Taken together, these innovations enable better care for the growing number of patients receiving anticoagulation therapy.

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