Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on a standard electrochemical detection method for measuring clotting time and calculating INR. There is no mention of AI, ML, or any algorithms beyond the direct calculation of INR from the measured Prothrombin Time.

Therapeutic

No
This device is an in vitro diagnostic (IVD) device used for monitoring the effect of warfarin on clotting time, not for direct therapeutic intervention.

Diagnostic

Yes

Explanation: The device is described as an "INRatio®2 PT/INR Monitoring System" used for "quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time." It is explicitly stated as being for "in vitro diagnostic use," which indicates its purpose in diagnosing or monitoring health conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of a "monitor and disposable test strips," indicating the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The intended use statement explicitly states: "The Alere INRatio®2 PT/INR Monitoring System (Professional Use) is intended for use outside of the body (in vitro diagnostic use)." and "The The Alere INRatio 2 PT/INR Home Monitoring System is intended for use outside of the body (in vitro diagnostic use)."

This clearly indicates that the device is designed to be used on samples taken from the human body (blood) to provide information about a person's health status, which is the definition of an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

GJS

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Alere INRatio 2 PT/INR Monitoring System (Professional Use): health care professionals.

Alere INRatio®2 PT/INR Home Monitoring System: properly selected suitably trained users (by prescription for home use or other order of a treating physician).

Care setting: In vitro diagnostic use.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Nonclinical Data: Performance testing verified that the modified INRatio2 PT/INR Test Strips have equivalent or better performance compared to the previously cleared INRatio PT/INR Test Strips with respect to precision, accuracy, and potential interferents when used with the INRatio2 PT/INR Monitoring Systems (Professional or Home). The performance claims currently in the labeling have been changed to reflect the performance of the INRatio2 PT/INR Test Strips.

Clinical Data: Clinical testing validated that the INRatio2 PT/INR Monitoring Systems (Professional and Home) utilizing the INRatio2 PT/INR Test Strips, when used by trained patient users or healthcare professionals, performed with acceptable accuracy compared to the reference method (the Sysmex CA-560 Anticoagulation Analyzer). Both user populations generated INR values with the INRatio2 PT/INR Monitoring Systems (Professional or Home), utilizing the INRatio2 PT/INR Test Strip, that were deemed accurate relative to the reference method. per ISO 17593:2007.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy: Slope = 0.9 – 1.1; Intercept ± 0.5 INR
Precision (Repeatability): Normal subjects Capillary %CV - 8.2%; Therapeutic Capillary %CV - 6.2%
Between Day Precision: Therapeutic Patient Self Testers Capillary %CV - 5.7% (Not Applicable for normal subjects, no longer reported)
Endogenous Interfering Factors:
Bilirubin: None up to 30 mg/dL
Hemoglobin/Hemolysis: None up to 1000 mg/dL
Lipemia/triglycerides: None up to 1500 mg/dL
Factor Sensitivity:
Factor II:

Regulation Number and Section

§ 864.7750 Prothrombin time test.

(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).

Summary

0

510(K) SUMMARY

MAY - 1 2012

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K110212

A. Submitter: Alere San Diego, Inc 9975 Summers Ridge Road San Diego, CA 92121 USA

Contact: Telephone: Fax: Email:
Mara Caler Regulatory Affairs 858.805.2083 858.805.7100 mara.caler@alere.com

April 12, 2012 Date Prepared:

B. Device Names:
Classification name Common/usual name Proprietary name

Prothrombin Time Test Prothrombin Time Test

Alere INRatio 2 PT/INR Monitoring System (Professional Use) Alere INRatio®2 PT/INR Home Monitoring System Alere INRatio®2 PT/INR Test Strip

INRatio® PT Monitoring System, K020679 C. Predicate Devices: INRatio® PT Monitoring System, K021923 INRatio® 2 PT/INR Monitoring System, K072727 INRatio® PT/INR Test Strip, K092987

D. 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.

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E. Intended Uses:

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/NR 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.

Comparison with the Predicate Devices: F.

The intended use (assay type and intended users) and the operation of the INRatio2 PT/INR Monitoring Systems (Professional and Home) and associated accessories and reagents have not changed. The INRatio2PT/INR Monitoring Systems (Professional or Home) are intended to measure International Normalized Ratio (INR) from fresh, capillary whole blood samples by both healthcare professional users and lay (trained patient users. The systems are not intended for screening. Based on the data and information presented here, the INRatio2 PT/INR Monitoring Systems (Professional or Home), when used with the User Guide by both Healthcare Professionals and Trained Patients, performed equivalently to the INRatio2 PT/INR Monitoring System K072727).

Furthermore, the INRatio2 PT/INR Test Strip is substantially equivalent to the previously cleared INRatio PT/INR Test Strip (K092987) currently marketed and distributed by Alere

2

North America. The current and modified INRatio2 PT/INR Test Strips both catalyze a clotting reaction in fresh, finger stick capillary whole blood samples The INRatio2 PT/INR Test Strips have a lower blood volume requirement. The INRatio2 PT/INR Test Strips can be used with the INRatio2 PT/INR monitors (Professional or Home). .

The INRatio®2 PT/INR Monitoring Systems (Professional Use and Home-use) are not intended for use in the quantitative determination of the international normalized ratio (INR) to monitor the effect of oral anticoagulant (warfarin) therapy on clotting time on patients who are transitioning from heparin treatment to warfarin therapy.

Nonclinical Data:

Performance testing verified that the modified INRatio2 PT/INR Test Strips have equivalent or better performance compared to the previously cleared INRatio PT/INR Test Strips with respect to precision, accuracy, and potential interferents when used with the INRatio2 PT/INR Monitoring Systems (Professional or Home). The performance claims currently in the labeling have been changed to reflect the performance of the INRatio2 PT/INR Test Strips.

G. Clinical Data

Clinical testing validated that the INRatio2 PT/INR Monitoring Systems (Professional and Home) utilizing the INRatio2 PT/INR Test Strips, when used by trained patient users or healthcare professionals, performed with acceptable accuracy compared to the reference method (the Sysmex CA-560 Anticoagulation Analyzer). Both user populations generated INR values with the INRatio2 PT/INR Monitoring Systems (Professional or Home), utilizing the INRatio2 PT/INR Test Strip, that were deemed accurate relative to the reference method. per ISO 17593:2007.

H. Conclusions Drawn from Testing

Based on the data and information presented here, the INRatio2 PT/INR Monitoring Systems (Professional and Home) , when used with the INRatio2 PT/INR Test Strip, are substantially equivalent to the INRatio (K020679; K021923) and INRatio2 (K072727) PT/INR Monitoring System and the INRatio PT/INR Test Strip (K092987) currently manufactured and distributed by Alere. The INRatio2 PT/INR Monitoring Systems (Professional and Home) have been verified and validated for ease of use by both Healthcare Professionals and Trained Patients in multiple healthcare professional and patient self-test user clinical trials (K020679: K021923, K072727 and this submission).

3

Alere	Traditional 510(K) Application	INRatio2PT/INR Monitoring System
Comparison Table of the INRatio/INRatio® 2 Monitoring PT/INR Test Systems utilizing the Current INRatio® PT/INR Test Strip vs.
the Alere™ INRatio®2 PT/INR Test Strip
Parameter	Current INRatio/INRatio2
PT/INR Monitoring Test Systems
utilizing current INRatio PT/INR
Test Strip
(K020679, K021923, K072727 and
K092987)	INRatio2 PT/INR Monitoring
System utilizing modified
Alere™ INRatio 2 PT/INR Test
Strip
(This submission)	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	Comment/Explanation of
difference
Intended Use	The Alere INRatio/INRatio2
PT/INR Monitoring System is used
for the quantitative measurement of
Prothrombin Time (PT) in fresh,
capillary whole blood. The
INRatio/INRatio2 PT/INR
Monitoring system is intended for
use outside the body (in vitro
diagnostic use). The
INRatio/INRatio2 PT/INR
Monitoring System is intended for
professional and home use by
people taking warfarin and other
oral anticoagulant (blood thinning)
therapy who need to monitor the
clotting time of their blood. The
INRatio/INRatio2 PT/INR
Monitoring System is not intended
to be used for screening purposes.	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.	Addition of patient self
testing to the intended use of
INRatio2 PT/INR Monitoring
System

:

·

4

	Traditional 510(K) Application	INRatio2PT/INR Monitoring System
	Comparison Table of the INRatio/INRatio®2 Monitoring PT/INR Test Systems utilizing the Current INRatio® PT/INR Test Strip vs.
the Alere™ INRatio®2 PT/INR Test Strip
Parameter	Current INRatio/INRatio2
PT/INR Monitoring Test Systems
utilizing current INRatio PT/INR
Test Strip
(K020679, K021923, K072727 and
K092987)	INRatio2 PT/INR Monitoring
System utilizing modified
Alere™ INRatio®2 PT/INR Test
Strip
(This submission)	Comment/Explanation of
difference
Alere INRatio®2 PT/INR Home
Monitoring System: The Alere
INRatio®2 PT/INR Home
Monitoring System, consisting of
the INRatio®2 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
Alere	Traditional 510(K) Application	INRatio2PT/INR Monitoring System
	Comparison Table of the INRatio/INRatio®2 Monitoring PT/INR Test Systems utilizing the Current INRatio® PT/INR Test Strip vs.
the Alere™ INRatio®2 PT/INR Test Strip
Parameter	Current INRatio/INRatio2
PT/INR Monitoring Test Systems
utilizing current INRatio PT/INR
Test Strip
(K020679, K021923, K072727 and
K092987)	INRatio2 PT/INR Monitoring
System utilizing modified
Alere™ INRatio®2 PT/INR Test
Strip
(This submission)	Comment/Explanation of
difference
Intended Users	Healthcare professionals and trained
patients on the prescription or other
order of a treating physician.	same	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.
Intended Sample	capillary whole blood	Capillary whole blood	Addition of patient self testing
to the intended use of the
Alere INRatio2 PT/INR
Monitoring System
Test Strip Monitor
Compatibility	INRatio (professional and patient
self test) and INRatio2
(professional) monitors	INRatio2 (professional and patient
self-test)	Addition of patient self tesing
to the intended use of Alere
INRatio2 PT/INR Monitoring
System
Mode of Measurement	Electrical Impedance	same	No change
Number of Reaction
Sites (and pairs of
electrodes)	3 (3 Pairs of Electrodes)	same	No change
Test Strip Layout	"Trident"	same	No change
Quality Control	Integrated in Test Strip	same	No change
	HIGH QC (therapeutic range)	same	No change
	LOW QC (normal range)	same	No change
Test Strip Graphics	Name of product	same	Name of product and thumbprint
Thumbprint and directional
Alere	Traditional 510(K) Application	INRatio2PT/INR Monitoring System
Comparison Table of the INRatio/INRatio®2 Monitoring PT/INR Test Systems utilizing the Current INRatio® PT/INR Test Strip vs. the Alere™ INRatio®2 PT/INR Test Strip
Parameter	Current INRatio/INRatio2
PT/INR Monitoring Test Systems
utilizing current INRatio PT/INR
Test Strip
(K020679, K021923, K072727 and
K092987)	INRatio2 PT/INR Monitoring
System utilizing modified
Alere™ INRatio®2 PT/INR Test
Strip
(This submission)	Comment/Explanation of
difference
Minimum Sample
Volume	15 μL	9.5 μL	and directional leading arrow
Test Time
Measurement Range	Approximately 1 min for INRatio2
INR: 0.7 - 7.5
PT: 7 - 75 sec	Approximately I min for INRatio2
INR: 0.7 - 7.5	leading arrow graphic added
to test strip for ease of use
Miniaturized micro-fluidic
design of Test Strip channels
allows for reduction in
minimum sample volume and
increases ease of use
Reference Range	INR: 0.7 - 1.2
PT: 6.5 - 11.9 sec	INR: 0.8 - 1.3	No change
No change; PT seconds units
are no longer reported in
package insert; INR units are
now industry standard
Reflects verified normal
reference range. PT range is
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
Alere	Traditional 510(K) Application	INRatio2PT/INR Monitoring System
Comparison Table of the INRatio/INRatio®2 Monitoring PT/INR Test Systems utilizing the Current INRatio® PT/INR Test Strip vs. the Alere™ INRatio®2 PT/INR Test Strip
Parameter	Current INRatio/INRatio2
PT/INR Monitoring Test Systems
utilizing current INRatio PT/INR
Test Strip
(K020679, K021923, K072727 and K092987)	INRatio2 PT/INR Monitoring
System utilizing modified
Alere™ INRatio®2 PT/INR Test
Strip
(This submission)	Comment/Explanation of
difference
Precision (Repeatability)	Normal subjects
Capillary %CV - 7.6%	Normal subjects
Capillary %CV - 8.2%	Minor change; reflects current
performance of the test strip
	Therapeutic
Capillary %CV - 5.9%	Therapeutic
Capillary %CV - 6.2%
Between Day Precision	Normal Subjects %CV - 8.5%	Therapeutic Patient Self Testers
Capillary %CV - 5.7%
Not Applicable	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
Endogenous Interfering
Factors:

Bilirubin | • None up to 20 mg/dL | • None up to 30 mg/dL | • Reflects current performance
of the test strip | |
| - Hemoglobin/Hemolysis | • None up to 500 mg/dL | • None up to 1000 mg/dL | • Reflects current performance
of the test strip | |
| - Lipemia/triglycerides | • None up to 1500 mg/dL | • None up to 1500 mg/dL | • No change | |
| Factor Sensitivity:
Factor II | • 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.

AND/OR

Prescription Use X (21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign Off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K / 1021

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