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October 5, 2016

Siemens receives FDA 510(k) clearance for Xprecia Stride Coagulation Analyser

Siemens Healthineers has obtained the US Food and Drug Administration (FDA) FDA 510(k) clearance for its hand-held portable coagulation analyser.

Siemens Healthineers has obtained the US Food and Drug Administration (FDA) FDA 510(k) clearance for its hand-held portable coagulation analyser.

The Xprecia Stride Coagulation Analyser has been developed to deliver fast and reliable Prothrombin Time International Normalsed Ratio (PT / INR) testing to pave the way for a point-of-care monitoring and management of oral anticoagulation therapy with warfarin, a vitamin K antagonist.

Ergonomically designed, the equipment features a large, intuitive touchscreen to allow an enhanced user experience while simplifying work flow, and improve overall testing accuracy.

"The Xprecia Stride analyser is designed to be safe, efficient and ergonomically friendly."

It is also fitted with an integrated barcode scanner, icons and animation in a colour display to offer an overall simplified workflow.

The Xprecia Stride analyser examines fresh capillary (fingerstick) whole blood samples and results are expressed as INR.

It uses the Dade Innovin reagent also used by Siemens Healthineers central lab analysers in order to reduce any potential variability.

Siemens Healthineers point of care senior vice president Michael Sampson said: “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.

“The Xprecia Stride analyser 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.”

The device ensures safety in procedure by including a test strip eject button which ejects a used test strip and easily dispose it without having to touch it which reduces the risk of biohazard exposure.

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