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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.

Device Description

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.

AI/ML Overview

The Alere INRatio2 PT/INR Monitoring System and INRatio2 PT/INR Test Strips were evaluated for performance against acceptance criteria. The study aimed to demonstrate equivalent or better performance compared to previously cleared devices.

Here's a breakdown of the information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparison table (pages 3-6) showing the performance of the new INRatio2 PT/INR Monitoring System utilizing the modified Alere™ INRatio2 PT/INR Test Strip against the previous INRatio/INRatio2 Monitoring PT/INR Test Systems.

Parameter	Acceptance Criteria (Previous INRatio/INRatio2 Systems)	Reported Device Performance (INRatio2 PT/INR System with modified strip)	Comment/Explanation of Difference
Intended Use	Quantitative measurement of PT in fresh capillary whole blood for professional and home use to monitor warfarin therapy. Not for screening.	Same, but with added specificity for "International Normalized Ratio (INR)" and "monitoring the effect of warfarin on clotting time by health care professionals" (Professional Use) and "by properly selected suitably trained users (by prescription for home use or other order of a treating physician)" (Home Use). Patients must be stabilized (>6 weeks) for Home Use.	Addition of patient self-testing to the intended use of the INRatio2 PT/INR Monitoring System (for Home Use). Clarification of limitations for both professional and home use regarding patients transitioning from heparin treatment to warfarin therapy.
Intended Users	Healthcare professionals and trained patients.	Same	No change.
Intended Sample	Capillary whole blood	Capillary whole blood	No change.
Test Strip Monitor Compatibility	INRatio (professional and patient self test) and INRatio2 (professional) monitors	INRatio2 (professional and patient self-test)	Addition of patient self-testing to the intended use of Alere INRatio2 PT/INR Monitoring System. The new strip is specifically designed for the INRatio2 monitors.
Mode of Measurement	Electrical Impedance	Same	No change.
Number of Reaction Sites	3 (3 Pairs of Electrodes)	Same	No change.
Test Strip Layout	"Trident"	Same	No change.
Quality Control	Integrated in Test Strip	Same	No change.
Test Strip Graphics	Name of product	Name of product and thumbprint and directional leading arrow	Thumbprint and directional leading arrow graphic added to test strip for ease of use.
Minimum Sample Volume	15 µL	9.5 µL	Miniaturized micro-fluidic design of Test Strip channels allows for reduction in minimum sample volume and increases ease of use.
Test Time	Approximately 1 min for INRatio2	Approximately 1 min for INRatio2	No change.
Measurement Range (INR)	0.7 - 7.5	0.7 - 7.5	No change.
Measurement Range (PT)	7 - 75 sec	Not reported	PT seconds units are no longer reported in package insert; INR units are now industry standard.
Reference Range (INR)	0.7 - 1.2	0.8 - 1.3	Reflects verified normal reference range. PT range is no longer reported in package insert; INR units are now industry standard.
Reference Range (PT)	6.5 - 11.9 sec	Not reported	PT seconds units are no longer reported in package insert; INR units are now industry standard.
Strip Calibration	Per WHO889:1999, using normal and therapeutic capillary whole blood samples vs. reference method using normal and therapeutic venous whole blood samples processed to plasma	Same	No change.
Accuracy	Slope = 0.9 – 1.1, Intercept ± 0.5 INR	Slope = 0.9 – 1.1, Intercept ± 0.5 INR	No change.
Precision (Repeatability) - Normal subjects Capillary %CV	7.6%	8.2%	Minor change; reflects current performance of the test strip. This is likely still within acceptable analytical variation.
Precision (Repeatability) - Therapeutic Capillary %CV	5.9%	6.2%	Minor change; reflects current performance of the test strip. This is likely still within acceptable analytical variation.
Between Day Precision - Normal Subjects %CV	8.5%	Not Applicable (Therapeutic Patient Self Testers Capillary %CV - 5.7%)	No longer reported on package insert as this number is not clinically useful; Between Day Precision can only be determined for normal subjects who are not the intended test population; This is now industry standard. The reported value (5.7%) for Therapeutic Patient Self Testers suggests good between-day precision in the relevant population.
Endogenous Interfering Factors:
- Bilirubin	None up to 20 mg/dL	None up to 30 mg/dL	Reflects current performance of the test strip, indicating improved resistance to bilirubin interference.
- Hemoglobin/Hemolysis	None up to 500 mg/dL	None up to 1000 mg/dL	Reflects current performance of the test strip, indicating improved resistance to hemoglobin interference.
- Lipemia/triglycerides	None up to 1500 mg/dL	None up to 1500 mg/dL	No change.
Factor Sensitivity:
- Factor II

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