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Alere INRatio®2 PT/INR Monitoring System (Professional Use): The Alere INRatio®2 PT/INR Monitoring System (Professional Use), consisting of the INRatio®2 Monitor and INRatio®2 PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals. The Alere INRatio 2 PT/INR Monitoring System (Professional Use) is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio®2 PT/INR Monitoring System (Professional Use) is not intended to be used for screening purposes. Limitations: The Alere INRatio 2 PT/INR Monitoring System (Professional Use) is not intended for use in patients who are transitioning from heparin treatment to warfarin therapy. Alere INRatio®2 PT/INR Home Monitoring System: The Alere INRatio®2 PT/INR Home Monitoring System, consisting of the INRation2 Home Monitor and INRatio®2 PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin therapy on clotting time by properly selected suitably trained users (by prescription for home use or other order of a treating physician). Patients must be stabilized (>6 weeks) on warfarin therapy. The The Alere INRatio 2 PT/INR Home Monitoring System is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio®2 PT/INR Home Monitoring System is not intended to be used for screening purposes. Limitations: The Alere INRatio®2 PT/INR Home Monitoring System is not intended for use in patients who are transitioning from heparin treatment to warfarin therapy.

The INRatio2 PT/INR Monitoring Systems (Professional and Home) perform a modified version of the one-stage Prothrombin Time test, using commercially available recombinant human thromboplastin (rhTP) reagent. The clot formed in the Prothrombin Time (PT) reaction is detected by a change in the electrical impedance of the sample during the coagulation process. The system consists of a monitor and disposable test strips. The monitor heats the test strip to the proper reaction temperature; a measure clot impedance and provides a result on a screen (user interface). The clotting reaction occurs on the Test Strip after the blood sample is applied. An International Normalized Ratio (INR) value is calculated from measured Prothrombin Time and the INR is displayed on the monitor to the user/patient.