microINR System

The microINR System is a prothrombin time (PT) test device that measures blood clotting via International Normalized Ratio (INR) to monitor warfarin anticoagulation therapy. It uses fresh capillary blood from a fingerstick and is intended for both patient self-testing and healthcare professional use in point-of-care settings, for patients 18 years and older who are stable on warfarin for at least 6 weeks.

The microINR Expert Meter incorporates additional connectivity functions (Wi-Fi and Ethernet on top of existing Bluetooth), a touchscreen display, a barcode scanner, and configurable settings for operator/patient identification. The test strips (microINR Chips) and measuring algorithm remain identical to predicate devices. All extra functionalities operate before or after the analytical test, with no changes to core performance characteristics.

Not stated in this summary.

The device uses identical test strips and measuring algorithm as three predicate devices (K180780, K201185, K231711), with no performance changes since initial clearance. The modifications are purely functional enhancements (connectivity, display, barcode scanning, configuration options) that operate outside the analytical measurement process. Software verification/validation, electromagnetic compatibility, cybersecurity analysis, and usability testing all met acceptance criteria with no new safety or effectiveness questions identified. Risk analysis showed no significant detectable risks compared to predicates, establishing that the added functionalities introduce no new issues of safety or effectiveness.