Xprecia Prime™ PT/INR test strips are intended exclusively for use with the Xprecia Prime™ and Xprecia Prime™ 4U coagulation analyzers. They enable the quantitative determination of prothrombin time (PT) and INR values in fresh capillary whole blood. Each strip contains dry reagents that enable electrochemical measurement of the coagulation process.

The system is used to monitor oral anticoagulant therapy with vitamin K antagonists. The result is displayed on the analyzer screen as the INR value and the PT time in seconds. Only dedicated Xprecia Prime™ PT/INR test strips should be used with these devices—other test strips are not compatible with the analyzers. The package contains 100 test strips, packed in 4 vials of 25 strips each. The Xprecia Prime™ model is intended for professional use, while the Xprecia Prime™ 4U allows for self-monitoring in accordance with the instructions for use and a doctor’s recommendations.

This product is intended for professional use and self-monitoring. This is a medical device. Use it in accordance with the instructions for use or the label.

Properties

• Intended exclusively for use with the Xprecia Prime™ and Xprecia Prime™ 4U analyzers
• sample material: fresh whole capillary blood
• test result: INR and PT time in seconds
• time to result: up to 60 seconds
• reporting range: 0.8–8.0 INR
• the strips contain dry reagents for electrochemical measurement of PT/INR
• the package contains 100 strips in 4 vials of 25 strips each
• The test strips are single-use
• The product is intended for professional use and self-monitoring

Package Contents

• 100 Xprecia Prime™ PT/INR test strips – 4 vials, 25 strips each
• 1 user manual

Learn more about the Xprecia Prime™ and Xprecia 4u analyzers.

How to perform the test?

1. Prepare the Xprecia Prime™ or Xprecia Prime™ 4U analyzer according to the user manual for the appropriate model.
2. Remove one test strip from the original vial and immediately reseal it tightly. The removed test strip must be used within 10 minutes.
3. Scan the code displayed by the analyzer to load information regarding calibration, lot number, and expiration date.
4. Insert the test strip into the analyzer port and wait until the device confirms it is ready for testing.
5. Obtain a fresh drop of capillary blood from your fingertip using a disposable lancet.
6. Apply the sample to the designated area of the test strip according to the messages displayed by the analyzer.
7. Do not move the test strip while the measurement is in progress. The PT and INR results will be displayed on the analyzer screen.

Application

• Anticoagulation clinics: for regular monitoring of INR levels in patients taking oral anticoagulants from the vitamin K antagonist class.
• Cardiology and internal medicine clinics, and primary care physicians: for monitoring anticoagulant therapy and supporting safe patient management.
• Hospitals, clinics, and point-of-care testing sites: for rapid PT/INR testing using the professional Xprecia Prime™ analyzer.
• Patients undergoing self-monitoring: for monitoring INR at home using the Xprecia Prime™ 4U analyzer, as directed by a physician.
• Patients on stable therapy with vitamin K antagonists: for regular monitoring of INR levels to support the assessment of treatment efficacy and safety.

Product and Responsible Entity Identification Information

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