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The microINR System measures prothrombin time (PT) expressed in International Normalized Ratio (INR), for monitoring oral anticoagulant therapy with warfarin. The microlNR System consists of a meter and chips (test strips) and uses fresh capillary whole blood from a fingerstick. The microlNR System is intended for patient self-testing use as well as for healthcare professionals at Point of Care settings. The microlNR System is intended for use in patients 18 years old or older. Patients must be stable on warfarin medication for at least 6 weeks before starting to use the microINR System. For Self-testing use: The System is intended for properly trained users under specific prescription of a physician. Caution: The microINR System is not in patients who are transitioning from heparin treatment to VKA therapy. The microINR System is not intended to be used for screening purposes.

The modified device microINR System containing the microINR Expert Meter is derived from the existing devices microINR Meter and microINR Link Meter. The change is for the incorporation of additional connectivity functions (Wi-Fi and Ethernet connectivity on top of the Bluetooth connectivity of the microINR Link), a touchscreen, a barcode scanner as well as other configurable settings and optional functions (such as the option of including operator and patient identification). All the actions related to the extra functionalities and configurable settings are set before or after performing the analytical test. The fundamental scientific technology of the modified device and its performance has not changed. No performance changes to the microINR System have been implemented since its initial clearance on K180780 and its home use clearance in K201185.

The microINR System measures prothrombin time (PT) expressed in International Normalized Ratio (INR), for monitoring oral anticoagulant therapy with warfarin. The microlNR System consists of a meter and chips (test strips) and uses fresh capillary whole blood from a fingerstick. The microlNR System is intended for patient self-testing use as well as for healthcare professionals at Point of Care settings. The microlNR System is intended for use in patients 18 years old or older. Patients must be stable on warfarin medication for at least 6 weeks before starting to use the microINR System. For Self-testing use: The System is intended for properly trained users under specific prescription of a physician. Caution: The microINR System is not in patients who are transitioning from heparin treatment to VKA therapy. The microINR System is not intended to be used for screening purposes.

The modified device microINR System containing the microINR Link Meter is derived from the existing device microINR Meter. The change is for the addition of Bluetooth connectivity to the meter. Bluetooth functionality stays inactive during the testing/measuring process. All the actions related to Bluetooth functionality are set before or after performing the analytical test. The fundamental scientific technology of the modified device and its performance has not changed. No performance changes to the microINR System have been implemented since its clearance on K201185.

The microlNR System measures prothrombin time (PT) expressed in International Normalized Ratio (INR), for monitoring oral anticoagulant therapy with warfarin. The microINR System consists of a microINR Meter and microINR Chip and uses fresh capillary whole blood from a fingerstick. The microINR System is intended for patient self-testing use as well as for healthcare professionals at Point of Care settings. The microlNR System is intended for use in patients 18 years old or older. Patients must be stable on warfarin medication for at least 6 weeks before starting to use the microINR System. For Self-testing use: The System is intended for properly trained users under specific prescription of a physician. Caution: The microINR System is not in patients who are transitioning from heparin treatment to VKA therapy. The microINR System is not intended to be used for screening purposes.

The microINR® System is comprised of a portable measuring device (microINR® Meter) and test strips (microINR® Chips) in which the capillary blood sample flows through capillary action. The microINR® Chip contains a reagent in dried form which consists of thromboplastin, and contains two symmetrical regions, the measuring channel and a control channel. The microINR® Meter measures International Normalized Ratio (INR) based on a Prothrombin Time (PT) assay carried out in the microINR® Chip based on microfluidic technology with machine vision detection. The microINR® System has a multi-level On-board Quality Control. Multiple key functions and elements of the system are checked and if deviations are detected, error messages are displayed and test results are not reported.

microINR System: The microlNR System (consisting of the microINR Chip) is intended for multiple-patient use by professional healthcare providers for the determination of International Normalized Ratio (INR) to monitor Oral Anticoagulation Therapy (OAT) warfarin. The microINR System uses fresh capillary whole blood. The microNR System is intended for in vitro diagnostic use at the point-of-care. The microlNR System is intended for use in patients 18 years of age and older. Patients must be stabilized (≥ 6 weeks) on warfarin. Caution: The microINR System is not intended for use in patients who are transitioning from heparin treatment to warfarin therapy. The microINR System is not intended to be used for screening purposes. The microINR chips are only intended to be used with the microINR meter. microINR Control Level A / microINR Control Level B: The microlNR Control is intended for quality control performed on the microINR Meter when used with the disposable microINR Chips. iLine Microsystems has available two microNR Control Levels (A and B) to perform quality control checks in the therapeutic range on the microINR System. The microINR Control is intended for professional use only.

The microINR® System is comprised of a portable measuring device (microINR® Meter) and test strips (microINR® Chips) in which the capillary blood sample flows through capillary action. The microINR® Chip contains a reagent in dried form which consists of thromboplastin, and contains two symmetrical regions, the measuring channel and a control channel. The microINR® Meter measures International Normalized Ratio (INR) based on a Prothrombin Time (PT) assay carried out in the microINR® Chip based on microfluidic technology with machine vision detection. The microINR® System has a multi-level On-board Quality Control. Multiple key functions and elements of the system are checked and if deviations are detected, error messages are displayed and test results are not reported. In addition to the microINR® On-Board Controls, the microINR® Control has been developed as an optional liquid quality control solution. The microINR® Control must be used only by healthcare professionals in order to meet the regulatory compliance requirements applicable to the facility where they are to be used. The microINR® Control contains lyophilized human citrated plasma from healthy donors (not heparinized plasma or plasma samples under oral anticoagulant therapy) modified by means of a dedicated process to simulate an abnormal coagulation sample and a calcium chloride solution. Before use, the lyophilized plasma must be reconstituted with the calcium chloride solution.