The CoaguSense Self-Test PT Monitoring System is an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in seconds and international normalized ratio (INR) units. It uses fresh capillary whole blood. It is intended for use by properly selected and suitably trained patients or their caregivers on the order of the treating doctor. Patients should be stabilized on warfarin-type (coumarin) anticoagulation therapy prior to self-testing with the CoaguSense Self-Test PT Monitoring System. It is not intended to be used for screening purposes.

Device Description

The CoaguSense Self-Test PT/INR Monitoring System is a portable medical device for the measurement of the Prothrombin Time (PT) using fresh capillary whole blood obtained from a finger prick. The test is performed by inserting a test strip into the meter and applying a drop of blood to the sample receptacle of the test strip. The meter automatically performs the PT test and the result is displayed as International Normalized Ratio (INR) and seconds (PT). The meter automatically stores all test results in memory. The device is powered by batteries or AC adapter. The disposable strip contains a rotating, spoked wheel that draws the sample into the reaction well after it is applied to the sample receptacle. The spokes rotate across the path of an infrared light beam and mix the liquid sample with the thromboplastin which is dried in the reaction well. When the sample clots, the clot is picked up by the spokes, interrupting the path of the infrared light beam that is detected by the meter. A bar code on each test strip conveys calibration and lot information. A control strip is also provided for quality control purposes.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a typical quantitative pass/fail format. Instead, it focuses on demonstrating comparable performance to professional healthcare provider (HCP) measurements and acceptable precision.

Acceptance Criteria (Implied)	Reported Device Performance
Strong correlation between patient self-test results and HCP results.	Correlation of 0.98 between trained users (patients) and HCPs.
Acceptable precision (low coefficient of variation).	Overall average CV% of 3.48% for subjects (patients) and 2.52% for HCPs.
Performs as designed and intended for lay users.	"The CoaguSense Self-Test PT/INR Monitoring System performs as designed and intended in the hands of lay users."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Test Set): Over 100 patients.
Data Provenance: The study was conducted at "clinical sites and in patient's homes," indicating a prospective, real-world setting. The country of origin is not explicitly stated, but the context of the 510(k) submission to the FDA suggests it's likely within the United States.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The "ground truth" in this context was established by healthcare practitioners (HCPs) taking PT/INR measurements. The document does not specify the number of HCPs, nor does it detail their specific qualifications (e.g., "radiologist with 10 years of experience"). It implies that these were standard clinical professionals involved in patient care and PT/INR testing.

4. Adjudication Method for the Test Set

The document describes a comparative method where patient self-test results were compared to results obtained by a healthcare practitioner. It doesn't mention an explicit "adjudication method" in terms of multiple experts resolving discrepancies. It's a direct comparison of two measurements – one from the patient, one from the HCP.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a traditional MRMC study as typically understood in diagnostic imaging (comparing multiple readers' interpretations of cases) was not performed. This study compared patient self-testing to HCP testing, not different readers' interpretations of the same "cases" (blood samples) in an MRMC framework.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device (CoaguSense Self-Test PT/INR Monitoring System) is a point-of-care testing device that the patient directly uses to measure their PT/INR. The "performance" being evaluated is the patient's ability to use the device accurately compared to a professional. Therefore, the concept of a "standalone" algorithm-only performance is not directly applicable in the same way it would be for an AI diagnostic imaging algorithm. The device is the "algorithm" and performs the measurement. The study assessed the overall system's performance in the hands of the end-user (patient).

7. The Type of Ground Truth Used

The ground truth for comparison was healthcare practitioner (HCP) obtained PT/INR test results. This represents a form of expert-derived reference standard.

8. The Sample Size for the Training Set

The document does not provide information regarding a separate "training set" or its sample size. The performance testing section describes a validation study. This suggests the device's measurement algorithm was likely developed and validated internally during product development, prior to this specific patient-use study, which served as a clinical validation.

9. How the Ground Truth for the Training Set Was Established

As no training set is described, there's no information on how its ground truth might have been established.

Summary

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1.3 510(k) Summary

REGULATORY AUTHORITY

Safe Medical Devices Act of 1990, 21 CFR 807.92

COMPANY NAME/CONTACT

CoaguSense, Inc. 42840 Christy St., Suite 110 Fremont, CA 94538 Phone: 510-270-5442 Phone: 866-903-0890

Contact: Robin Bush Sawamura Regulatory Affairs

Date Prepared: January 18, 2010

NAME OF DEVICE

Trade Name:	CoaguSense Self-Test PT/INR Monitoring System
Common Name:	Prothrombin Time Test
Classification Name:	Prothrombin Time Test

RegulationNumber	ProductCode	Classification Name	DeviceClass
864.7750	GJS	Prothrombin Time Test	II

PREDICATE DEVICES

ImmediaTM Prothrombin Time System (Farallon Medical, Inc.): #K050243 .
INRatio PT Self-Test Monitoring System (HemoSense, Inc.): #K021923 .
. INRatio 2 PT Self-Test Monitoring System (HemoSense, Inc.): #K072727
CoaguChekTM PT-S Test (Roche Diagnostics, Inc.): #K030845 .

DEVICE DESCRIPTION

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The meter automatically stores all test results in memory. The device is powered by batteries or AC adapter. The disposable strip contains a rotating, spoked wheel that draws the sample into the reaction well after it is applied to the sample receptacle. The spokes rotate across the path of an infrared light beam and mix the liquid sample with the thromboplastin which is dried in the reaction well. When the sample clots, the clot is picked up by the spokes, interrupting the path of the infrared light beam that is detected by the meter. A bar code on each test strip conveys calibration and lot information. A control strip is also provided for quality control purposes.

INDICATION FOR USE STATEMENT

SUBSTANTIAL EQUIVALENCE COMPARISON

The CoaguSense Self-Test PT/INR Monitoring System is substantially equivalent in technology, features, design, materials and intended use to other cleared medical device products that measure Prothrombin Time in human blood. This device is the identical mechanical device to the Immedia™ PT System, that was cleared in #K050243, but the labeling has been changed for physician-directed. self-test use by patients. The INRatio and CoaguChek PT-S PT/INR meters are also cleared for self testing by patients.

PERFORMANCE TESTING

Verification and validation testing activities were conducted to establish the performance. functionality and reliability characteristics of CoaguSense Self-Test PT/INR Monitoring System.

Testing included electrical safety, environmental testing, system testing, impact testing, and functional testing. A hazard and software risk analysis also was performed with associated risks mitigated through design or labeling.

The CoaguSense Self-Test PT/INR Monitoring System was tested under conditions of actual use at clinical sites and in patient's homes to validate that the system performed as intended and met the users' expectations. Over 100 patients performed a self-test at home every 3-4 days over a 10-week period. The study compared CoaguSense PT/INR test results obtained by the patient to those obtained by the healthcare practitioner (HCP). The study results demonstrated that the lay patient user with no laboratory training can be trained to use the CoaguSense Self-Test PT/INR Monitoring System to obtain results that are comparable to results obtained by the health care professional. Results obtained by the trained users and the

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HCPs produced a correlation of 0.98. The precision obtained by users on the CoaguSense device was an overall average CV% of 3.48% for subjects and 2.52% for HCPs. The CoaguSense Self-Test PT/INR Monitoring System performs as designed and intended in the hands of lay users.

CONCLUSION

CoaguSense Self-Test PT/INR Monitoring System is substantially equivalent in technology, features, and indications for use to devices cleared under the Federal Food, Drug and Cosmetic Act. The device has the same fundamental scientific technology and intended use as the predicate devices. The device introduces no new questions concerning the safety or efficacy and is, therefore, substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002

CoaguSense, Inc. c/o Mr. Douglas Patterson Chief Executive Officer 42840 Christy Street, Suite 110 . Fremont, CA 94538

APR 0 7 2010

Re: K093243

Trade/Device Name: CoaguSense Self-Test Prothrombin Time/INR Monitoring System Regulation Number: 21 CFR §864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: Class II Product Code: GJS Dated: March 2, 2010 Received: March 4, 2010

Dear Mr. Patterson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed

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Page 2 - Mr. Douglas Patterson

predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

ia m chan

Maria M. Chan, Ph.D Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known):	#K093243
Device Name:	CoaguSense Self-Test PT/INR Monitoring System

Indications for Use:

The CoaguSense Self-Test PT Monitoring System is an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in seconds and international normalized ratio (INR) units. It uses fresh capillary whole blood. It is intended for use by properly selected and suitably trained patients or their careqivers on the order of the treating doctor. Patients should be stabilized on warfarin-type (coumarin) anticoagulation therapy prior to self-testing with the CoaguSense Self-Test PT Monitoring System. It is not intended to be used for screening purposes.

Prescription Use(Part 21 CFR 801 Subpart D)	☑
	AND/OR
Over-The-Counter Use(21 CFR 801 Subpart C)

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

	Concurrence of ØDRH/Office of In Vitro Diagnostic Devices (OIVD)
Senior

Division Sign-Off Office of In Vitro Diagnòstic-Device Evaluation and Safety

510(k) KD93243

Page 1 of

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).