FDA clears use of coagulation analyzer

Finger prick

The US Food and Drug Administration (FDA) has granted 510(k) clearance for the Xprecia Stride Coagulation Analyzer from Siemens Healthcare Diagnostics.

This hand-held, portable coagulation analyzer is designed to deliver prothrombin time/international normalized ratio (PT/INR) testing for point-of-care (POC) monitoring and management of oral anticoagulation therapy with the vitamin K antagonist warfarin.

The Xprecia Stride Coagulation Analyzer is the first POC PT/INR device cleared by the FDA based on the new rules published in March 2016.

The analyzer uses fresh capillary whole blood, and results are expressed as INR. The Xprecia Stride Coagulation Analyzer utilizes the same Dade® Innovin® reagent used by Siemens Healthineers central lab analyzers to minimize any potential for variability.

Research has shown the performance of the Xprecia Stride Coagulation Analyzer to be equivalent to a reference laboratory hemostasis system,* with results available within minutes.

According to Siemens, the Xprecia Stride Coagulation Analyzer includes a number of innovations and features not found on most other POC analyzers.

The Xprecia Stride Coagulation Analyzer has a touchscreen interface with step-by-step instructions that help guide the user.

To further enhance usability, the analyzer features simple icons and animation in a color display more commonly found in mobile devices than medical instruments.

The Xprecia Stride Coagulation Analyzer is no bigger than a smartphone and weighs just 10.5 oz, so it can be held at virtually any angle and brought directly to the patient’s finger for blood sample collection.

The analyzer has an integrated barcode scanner intended to simplify data capture and improve patient workflow. The scanner offers patient and operator ID entry.

The Xprecia Stride Coagulation Analyzer has an operator lockout feature that restricts the analyzer’s use to trained staff only.

And the analyzer includes 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.

For more information on the Xprecia Stride Coagulation Analyzer, visit www.siemens.com/xprecia.

*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.”

Finger prick

The US Food and Drug Administration (FDA) has granted 510(k) clearance for the Xprecia Stride Coagulation Analyzer from Siemens Healthcare Diagnostics.

This hand-held, portable coagulation analyzer is designed to deliver prothrombin time/international normalized ratio (PT/INR) testing for point-of-care (POC) monitoring and management of oral anticoagulation therapy with the vitamin K antagonist warfarin.

The Xprecia Stride Coagulation Analyzer is the first POC PT/INR device cleared by the FDA based on the new rules published in March 2016.

The analyzer uses fresh capillary whole blood, and results are expressed as INR. The Xprecia Stride Coagulation Analyzer utilizes the same Dade® Innovin® reagent used by Siemens Healthineers central lab analyzers to minimize any potential for variability.

Research has shown the performance of the Xprecia Stride Coagulation Analyzer to be equivalent to a reference laboratory hemostasis system,* with results available within minutes.

According to Siemens, the Xprecia Stride Coagulation Analyzer includes a number of innovations and features not found on most other POC analyzers.

The Xprecia Stride Coagulation Analyzer has a touchscreen interface with step-by-step instructions that help guide the user.

To further enhance usability, the analyzer features simple icons and animation in a color display more commonly found in mobile devices than medical instruments.

The Xprecia Stride Coagulation Analyzer is no bigger than a smartphone and weighs just 10.5 oz, so it can be held at virtually any angle and brought directly to the patient’s finger for blood sample collection.

The analyzer has an integrated barcode scanner intended to simplify data capture and improve patient workflow. The scanner offers patient and operator ID entry.

The Xprecia Stride Coagulation Analyzer has an operator lockout feature that restricts the analyzer’s use to trained staff only.

And the analyzer includes 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.

For more information on the Xprecia Stride Coagulation Analyzer, visit www.siemens.com/xprecia.

*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.”

Finger prick

The US Food and Drug Administration (FDA) has granted 510(k) clearance for the Xprecia Stride Coagulation Analyzer from Siemens Healthcare Diagnostics.

This hand-held, portable coagulation analyzer is designed to deliver prothrombin time/international normalized ratio (PT/INR) testing for point-of-care (POC) monitoring and management of oral anticoagulation therapy with the vitamin K antagonist warfarin.

The Xprecia Stride Coagulation Analyzer is the first POC PT/INR device cleared by the FDA based on the new rules published in March 2016.

The analyzer uses fresh capillary whole blood, and results are expressed as INR. The Xprecia Stride Coagulation Analyzer utilizes the same Dade® Innovin® reagent used by Siemens Healthineers central lab analyzers to minimize any potential for variability.

Research has shown the performance of the Xprecia Stride Coagulation Analyzer to be equivalent to a reference laboratory hemostasis system,* with results available within minutes.

According to Siemens, the Xprecia Stride Coagulation Analyzer includes a number of innovations and features not found on most other POC analyzers.

The Xprecia Stride Coagulation Analyzer has a touchscreen interface with step-by-step instructions that help guide the user.

To further enhance usability, the analyzer features simple icons and animation in a color display more commonly found in mobile devices than medical instruments.

The Xprecia Stride Coagulation Analyzer is no bigger than a smartphone and weighs just 10.5 oz, so it can be held at virtually any angle and brought directly to the patient’s finger for blood sample collection.

The analyzer has an integrated barcode scanner intended to simplify data capture and improve patient workflow. The scanner offers patient and operator ID entry.

The Xprecia Stride Coagulation Analyzer has an operator lockout feature that restricts the analyzer’s use to trained staff only.

And the analyzer includes 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.

For more information on the Xprecia Stride Coagulation Analyzer, visit www.siemens.com/xprecia.

*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.”