COAGUCHEK XS SYSTEM

K062925 · Roche Diagnostics Corp. · GJS · Jan 29, 2007 · Hematology

Device Facts

• Record ID: K062925
• Device Name: COAGUCHEK XS SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: GJS · Hematology
• Decision Date: Jan 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7750
• Device Class: Class 2

Intended Use

The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor. Users should be stabilized on anticoagulation medications such as Coumadin® or warfarin prior to self-testing with the CoaguChek XS System. The system uses capillary blood.

Device Story

CoaguChek XS System is a point-of-care diagnostic device for home monitoring of prothrombin time (PT) in patients on anticoagulation therapy. System consists of a handheld meter and disposable test strips containing human recombinant tissue factor. User applies capillary blood sample to test strip; electrochemical sensor detects thrombin activity via amperometric measurement. Meter converts electrical signal to INR value. Device includes on-board quality control (OBC) to verify strip integrity; if QC fails, no result is displayed. Meter stores up to 100 results with timestamps. Patients or caregivers operate device at home; results assist in managing anticoagulation therapy. Data transfer via infrared communication. System provides patient-side monitoring, reducing need for frequent clinical visits.

Clinical Evidence

Clinical study compared self-trained patient results (N=258) against healthcare professional results using the same meter. Results showed high correlation (Slope=1.00, Intercept=0.0, r=0.974). Precision study (N=222 patients, N=257 professionals) demonstrated comparable CVs (5.19% vs 5.38%) and SDs (0.132 vs 0.135), confirming self-testing accuracy and precision are equivalent to professional use.

Technological Characteristics

Electrochemical system with amperometric detection of thrombin activity. Test strips utilize human recombinant tissue factor calibrated to ISI 1.0. Meter features infrared communication, memory for 100 results, and bi-level on-board quality control (OBC) integrated into test strips. OBC monitors for reagent defects, capillary compression, electrode defects, and environmental damage (humidity/light/temperature). Code chip provides lot-specific calibration data.

Indications for Use

Indicated for patients on anticoagulation therapy (e.g., Coumadin, warfarin) requiring prothrombin time (INR) monitoring. Intended for use by properly selected, trained patients or caregivers in home settings upon physician prescription. Patients must be stabilized on medication prior to use.

Regulatory Classification

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).

Predicate Devices

• Roche Diagnostics CoaguChek XS System (professional) (K060978)

Submission Summary (Full Text)

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K062925

JAN 2 9 2007

## 510(k) Summary

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter name, address, contact | Roche Diagnostics Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br><br>Contact Person: Luann Ochs<br><br>Date Prepared: January 29, 2007 |
| 2) Device name | Proprietary name: CoaguChek® XS System<br>Common name: Prothrombin time test<br>Classification name: Prothrombin time test |
| 3) Predicate device | The Roche Diagnostics CoaguChek XS System (patient self-testing) is substantially equivalent in materials, design and function to other products that measure prothrombin time INR in human blood. Most notably, it is substantially equivalent to the Roche Diagnostics CoaguChek XS System (professional). In fact, it is identical in materials, design and function to the CoaguChek XS System (professional) except the labeling has been modified and validated for patient self-testing. |
| 4) Device Description | The CoaguChek XS is a 3rd generation Roche Diagnostic's CoaguChek meter which was cleared for professional use under premarket notification K060978.<br><br>This premarket notification is being submitted to obtain clearance for patient self-testing. |
| 5) Intended Use | The CoaguChek XS PT test strips are part of the CoaguChek XS<br>System. The CoaguChek XS System measures blood-clotting time for people<br>who are taking anticoagulation medications such as Coumadin® or<br>warfarin. The CoaguChek XS System uses blood from a finger stick. The<br>system is intended for properly selected and suitably trained users or their<br>caregivers on the prescription or other order of the treating doctor. Users<br>should be stabilized on anticoagulation medications such as Coumadin® or<br>warfarin prior to self-testing with the CoaguChek XS System. |
| 6) Comparison to<br>Predicate Device | The following characteristics have been previously submitted, reviewed<br>and cleared under the premarket notification for the CoaguChek XS<br>System (K060978):<br>•Factor Sensitivity<br>•Heparin Sensitivity<br>•Hematocrit Effect<br>•Interfering Substances<br>•Normal Range<br>•Measuring Range<br>•Test Strip Stability<br>•Integrated Quality Control<br>•Instrument Failsafes<br>•Calibration<br>•Software Development<br>These characteristics are not impacted by the new user population.<br>The use of the system by self-testers was validated by an external user<br>study that was conducted as the system is intended to be used. Following<br>self-directed training, the subjects self-tested in the home setting for up to<br>8 weeks. The subjects also had 3 scheduled visits to their study site to<br>collect user vs. technician data as well as user vs. reference method (Dade<br>Innovin on a Sysmex analyzer) data.<br>The study results successfully demonstrated that self-trained subjects can<br>obtain results that are equivalent to healthcare professionals and to the<br>reference method. This study also demonstrated that self-tester results are<br>consistent over time. |

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The performance characteristics that are impacted by the new user population 7) Performance characteristics were evaluated. The following information has been incorporated into our draft patient self-testing insert.

| Claim | Statement | | | |
|-----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|-------|--|
| Accuracy | A study was conducted comparing test results<br>obtained by self-trained patients with those obtained<br>by healthcare professionals using the CoaguChek XS<br>meter. The correlation was very good, as indicated by<br>the following statistics: N = 258, Slope = 1.00,<br>Intercept = 0.0 and Correlation Coefficient = 0.974.<br>This study shows that self-trained patients are able to<br>obtain results that are as accurate as those obtained by<br>healthcare professionals trained in the use of the<br>CoaguChek XS meter. | | | |
| Precision | A study was conducted and the precision of duplicates<br>for capillary blood results was calculated for both<br>self-trained patients and healthcare professionals.<br>The following results were obtained: | | | |
| | Patient Results<br>Professional Results | | | |
| | N | 222 | 257 | |
| | Mean | 2.55 | 2.50 | |
| | SD | 0.132 | 0.135 | |
| | CV | 5.19 | ર :38 | |
| | This study shows that self-trained patients are able to<br>obtain results that are as precise as those obtained by<br>healthcare professionals trained in the use of the<br>CoaguChek XS meter. | | | |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

ROCHE Diagnostics Corp. C/O Jennifer Tribbett 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250

JAN 2 9 2007

Re: k062925

Trade/Device Name: CoaguChek® XS System for Patient Self-testing Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: Class II Product Code: GJS Dated: September 27, 2006 Received: September 28, 2006

Dear Ms. Tribbett:

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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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

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marketed 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 Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Robert A. Becker, Jr.

Robert L. Becker, Jr., MD, PhI Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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HFZ-404 510(k) Staff HFZ- 440 Division D.O.

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## Indications for Use

510(k) Number (if known):_-K060978- |< 0 6 2 9 2 5

CoaguChek® XS System for Patient Self-Testing Device Name:

Indications For Use:

The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin® or warfarin. The CoaguChek XS System uses blood from a finger stick. The system is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor. Users should be stabilized on anticoagulation medications such as Coumadin® or warfarin prior to self-testing with the CoaguChek XS System.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suphine Bautista

Division Sign

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K062925