COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING

K030845 · Roche Diagnostics Corp. · GJS · May 22, 2003 · Hematology

Device Facts

• Record ID: K030845
• Device Name: COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING
• Applicant: Roche Diagnostics Corp.
• Product Code: GJS · Hematology
• Decision Date: May 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7750
• Device Class: Class 2

Intended Use

For quantitative prothrombin time testing in fresh capillary blood with the CoaguChek System by properly selected and suitably trained patients or their caregivers on the prescription or other order of the treating doctor.

Device Story

CoaguChek PT•S Test system measures prothrombin time (PT) in fresh capillary blood. Device consists of test strips used with CoaguChek monitor. Patient applies blood drop to strip; blood enters reaction chamber containing reagents and iron particles. Monitor generates alternating magnetic fields; iron particles move within sample. Coagulation endpoint detected when clot stops particle movement. Result displayed on monitor. Used by patients/caregivers at home for monitoring anticoagulant therapy (e.g., warfarin). Enables self-management of therapeutic range; reduces need for clinical visits.

Clinical Evidence

Bench testing only. Accuracy compared to predicate (N=84, slope 1.011, intercept -0.03, r=0.978). Precision evaluated for patient and professional results; patient results showed mean 2.33, SD 0.15, CV 6.45% (N=841).

Technological Characteristics

Test strip contains human recombinant thromboplastin, stabilizers, heparin neutralizing agent, and preservatives. Sensing principle: magnetic particle movement in alternating magnetic field. Connectivity: standalone monitor. Form factor: disposable test strip.

Indications for Use

Indicated for patients requiring oral anticoagulant therapy (e.g., warfarin) who need prothrombin time (PT) monitoring. Intended for use by trained patients or caregivers in a home setting under physician prescription.

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

• CoaguChek System for Prothrombin Time Self-Testing (K962571)

Submission Summary (Full Text)

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K03084/5

510(k) Summary

MAY 22 2003

| 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>P.O. Box 50457<br>Indianapolis, IN 46250-0457<br>Contact Person: Jennifer Tribbett<br>Date Prepared: March 14, 2003 |
| 2) Device name | Proprietary name: CoaguChek™ PT•S Test for Prothrombin Time Self-Testing<br>Common name: Prothrombin time test<br>Classification name: Prothrombin time test |
| 3) Predicate device | The Roche Diagnostics PT•S test strip and controls on the CoaguChek System for Patient Self-Testing are substantially equivalent to other products in commercial distribution intended for Patient Self-Testing. Most notably, the system is substantially equivalent to the currently marketed CoaguChek System for Prothrombin Time Self-Testing (K962571). |

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## 510(k) Summary, Continued

The CoaguChek PT.S Test is for quantitative prothrombin time testing in 4) Device Description fresh capillary blood with the CoaguChek System by properly selected and suitably trained patients or their caregivers on the prescription or other order of the treating doctor.

> Blood coagulation is one of the body's protective responses. Blood clots (thrombi) form as a direct response to vessel injury, preventing excessive loss of blood. Certain disease conditions require oral anticoagulants, sometimes known as blood thinners. Warfarin, sometimes known as Coumadin®, is a commonly used anticoagulant. Patients on warfarin must be carefully monitored to ensure the anticoagulant level is maintained in the therapeutic range. One method for monitoring the anticoagulant level is by using the one-stage Prothrombin Time (PT) Test. The PT.S test strip uses a modified version of this method.

> The PT.S test strip, used as directed with the CoaguChek monitor, will accurately measure blood PT values. After placing a drop of fresh whole blood on the test strip, the blood is drawn into the reaction chamber and mixed with reagents that cause coagulation to begin. In the test strip, tiny iron particles are mixed with the sample. Alternating magnetic fields cause the iron particles to move within the sample. The endpoint is reached when the blood clot stops the iron particles from moving. The PT result is then displayed by the monitor.

For quantitative prothrombin time testing in fresh capillary blood with the 5) Intended use CoaguChek System by properly selected and suitably trained patients or their caregivers on the prescription or other order of the treating doctor.

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## 510(k) Summary, Continued

6) Similarities to and differences from predicate device

| Topic | CoaguChek System for Prothrombin<br>Time Self-Testing<br>(K962571) | CoaguChek System for<br>Prothrombin Time Self-Testing<br>with the PT•S Test Strip and<br>Controls |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For quantitative prothrombin time (PT)<br>testing in fresh capillary blood with the<br>CoaguChek System by properly selected<br>and suitably trained patients or their<br>caregivers on the prescription or other<br>order of the treating doctor. | Same |
| Test Principle | After placing a drop of fresh capillary<br>blood on the test strip, the blood drawn<br>into the reaction chamber and mixed<br>with reagents that cause coagulation to<br>begin. In the test strip, tiny iron particles<br>are mixed with the sample. Alternating<br>magnetic fields cause the iron particles<br>to move within the sample. The test is<br>complete when the blood clot stops the<br>iron particles from moving. The PT<br>result is then displayed by the monitor. | Same |
| Reagents | Each test strip contains rabbit<br>thromboplastin, stabilizers and<br>preservatives | Each test strip contains human<br>recombinant thromboplastin,<br>stabilizers, a heparin neutralizing<br>agent and preservatives |
| International<br>Sensitivity Index | ISI is approximately 2 | ISI is approximately 1 |
| Storage and<br>Stability | You may store strips at room<br>temperature for up to 60 days, then<br>refrigerate until the "Use By" date. | (Improved) You may store strips at<br>room temperature for up to 90 days,<br>then refrigerate until the "Use By"<br>date. |
| Topic | CoaguChek System for Prothrombin<br>Time Self-Testing<br>(K962571) | CoaguChek System for<br>Prothrombin Time Self-Testing<br>with the PT•S Test Strip and<br>Controls |
| Storage and<br>Stability | Remove one test strip foil pouch from<br>the refrigerator. Allow the sealed pouch<br>to set at room temperature for at least<br>five minutes before opening for testing. | (Improved) A warm up period of 5<br>minutes is not necessary with the<br>PT•S test strip. |
| Storage and<br>Stability | Use the test strip within four minutes<br>after opening the foil pouch. | (Improved) Use the test strip within<br>ten minutes after opening the foil<br>pouch |
| Quality Control<br>Recommendation | Two levels of control should be tested<br>upon receipt of each test strip carton<br>and each day of use. | Same |
| Verified Clinical<br>Range | 0.6 - 8.0 INR | 0.8 - 8.0 INR |
| Accuracy | N = 315 observations<br>Slope = 0.973<br>Intercept = 0.05<br>Correlation Coefficient = 0.966 | N = 84 observations<br>Slope = 1.011<br>Intercept = -0.03<br>Correlation Coefficient = 0.978 |
| Precision | Patient Results<br>Professional Results | Patient Results<br>Professional Results |
| | N<br>1070<br>Mean<br>3.81<br>SD<br>0.39<br>CV<br>10.31 | N<br>841<br>Mean<br>2.33<br>SD<br>0.15<br>CV<br>6.45 |
| | N<br>40<br>Mean<br>3.78<br>SD<br>0.35<br>CV<br>9.30 | N<br>140<br>Mean<br>2.35<br>SD<br>0.14<br>CV<br>5.79 |

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## New System vs. Predicate System -Continued-

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Jennifer Tribbett Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457

MAY 22 2003

Re: k030845

> Trade/Device Name: CoaguChek™ PT•S Test for Prothrombin Time Self-Testing Regulation Number: 21 CFR § 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: II Product Code: GJS Dated: March 14, 2003 Received: March 17, 2003

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

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If you desire specific information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K030845 510(k) Number (if known):

CoaguChek™ PT•S Test for Prothrombin Time Self-Testing Device Name:

Indications for Use:

For quantitative prothrombin time testing in fresh capillary blood with the CoaguChek System by properly selected and suitably trained patients or their caregivers on the prescription or other order of the treating doctor.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Quxeline Bautista

(Division Sign-Q Division of Clinical Laboratory Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)