COAGUCHEK XS PLUS PST SYSTEM

K092940 · Roche Diagnostics Corp. · GJS · Mar 5, 2010 · Hematology

Device Facts

• Record ID: K092940
• Device Name: COAGUCHEK XS PLUS PST SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: GJS · Hematology
• Decision Date: Mar 5, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7750
• Device Class: Class 2

Intended Use

The CoaguChek® XS Plus System for Patient Self-Testing measures blood-clotting time for people who are taking warfarin anticoagulation medications. The CoaguChek XS Plus System for Patient Self-Testing 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.

Device Story

Portable coagulation monitoring system; measures prothrombin time (PT) in patients on oral anticoagulants. Input: 10μL whole blood from finger stick applied to test strip. Operation: Amperometric detection; thromboplastin activates coagulation cascade; thrombin cleaves substrate to generate electrical signal; signal converted to INR value. System includes onboard quality control (OBC) assessing strip integrity; QC lockout prevents testing if QC fails. Used in home setting by patients or caregivers. Output: INR value displayed on meter; stores up to 500 results with metadata. Benefits: Enables patient self-testing and monitoring of anticoagulation therapy outside clinical settings.

Clinical Evidence

Three-site user study (N=103) comparing trained patient self-testing to healthcare professional measurements over 8 weeks. Regression analysis (N=307) showed correlation of 0.963 (slope 1.00, intercept 0.00). Mean bias was 1.6% overall, meeting the <10% acceptance criterion. Precision study (N=296-308) showed CV of 5.47% for users and 4.12% for professionals. Normal range testing (N=121) confirmed 0.9-1.1 INR range.

Technological Characteristics

Electrochemical test system; uses human recombinant thromboplastin reagent. Amperometric sensing principle. Portable meter form factor. Features onboard bi-level quality control (OBC) integrated into test strips. Data storage for 500 results. Infrared communication for data transfer. Code chip used for lot-specific calibration and QC ranges.

Indications for Use

Indicated for patients on warfarin anticoagulation therapy requiring prothrombin time (PT) monitoring via finger stick blood samples. Intended for use by trained patients or caregivers 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

• Roche Diagnostics CoaguChek XS Plus System (professional) (K071041)

Submission Summary (Full Text)

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Kosaayd

MAR - 5 2010

# 510(k) Summary

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter<br>name, address,<br>contact | Roche Diagnostics Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br><br>Contact Person: Jennifer Tribbett<br><br>Date Prepared: September 22, 2009 |
| 2) Device name | Proprietary name: CoaguChek® XS Plus System<br>Common name: Prothrombin time test<br>Classification name: Prothrombin time test |
| 3) Predicate<br>device | The Roche Diagnostics CoaguChek XS Plus System (patient self-testing) is<br>substantially equivalent in materials, design and function to other products<br>that measure prothrombin time INR in human blood. Most notably, it is<br>substantially equivalent to the Roche Diagnostics CoaguChek XS Plus<br>System (professional). In fact, it is identical in materials, design and function<br>to the CoaguChek XS Plus System (professional) except the labeling has been<br>modified and validated for patient self-testing.<br><br>The labeling created for the CoaguChek XS Plus System (patient self-testing)<br>is substantially equivalent in format and content to the CoaguChek XS<br>System (patient self-testing). |
| 4) Device<br>Description | The CoaguChek XS Plus System was previously cleared for professional use<br>under premarket notification K071041.<br><br>This premarket notification is being submitted to obtain clearance for patient<br>self-testing. |
| 5) Intended Use | The CoaguChek XS Plus System measures blood-clotting time for people<br>who are taking warfarin anticoagulation medications. The CoaguChek XS<br>Plus System uses blood from a fingerstick. The system is intended for<br>properly selected and suitably trained users or their caregivers on the<br>prescription or other order of the treating doctor. |
| 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 Plus<br>System (K071041): |
| | • Factor Sensitivity |
| | • Heparin Sensitivity |
| | • Hematocrit Effect |
| | • Interfering Substances |
| | • Normal Range |
| | • Measuring Range |
| | • Test Strip Stability |
| | • Integrated (on-board) Quality Control |
| | • Instrument Failsafes |
| | • Calibration |
| | • Software Development |
| | These characteristics are not impacted by the new user population. |
| | 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>face-to-face training, the subjects self-tested in the home setting for up to 8<br>weeks. The subjects also had 3 scheduled visits to their study site to<br>collect user vs. technician data. |

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The study results successfully demonstrated that self-trained subjects can obtain results that are equivalent to healthcare professionals. This study also demonstrated that self-tester results are 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 obtained by<br>trained users with those obtained by healthcare<br>professionals, when both were using the CoaguChek XS<br>Plus System. The correlation was very good, as indicated<br>by the following statistics: N = 307, Slope = 1.000,<br>Intercept = 0.0 and Correlation Coefficient = 0.963. This<br>study shows that trained users are able to obtain results<br>that are as accurate as those obtained by healthcare<br>professionals trained in the use of the CoaguChek XS Plus<br>System. |

#### Passing-Bablock Regression analysis (Subject vs. Technician) (Overall)

Image /page/2/Figure/3 description: This image is a scatter plot that compares Subject INR to Technician INR. The x-axis represents Technician INR, and the y-axis represents Subject INR, both ranging from 0 to 7. The plot includes a regression line and the equation Y = 0.000 + 1.000 * X, with a sample size of 307. The correlation coefficient (r) is 0.9632, and t = 0.8970.

Continued on next page

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| Study User<br>Demographics | A clinical study was conducted by Roche Diagnostics,<br>consisting of four visits to the clinical site. Informed<br>consent and randomization occurred at visit 1.<br>Testing began at visit 2. 103 patients completed all<br>visits. The following table outlines the demographic<br>information for the trained users who completed all<br>visits. |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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| Demographic | Number | Percent |
|--------------------------------------------------------------------|--------------|---------|
| Total number of users | 103 | 100% |
| Males | 57 | 55.3% |
| Females | 46 | 44.7% |
| Age range (years) | 34-86 | N/A |
| Mean age (years) | 69 | N/A |
| Age 65-69 years | 20 | 19.4% |
| Age 70-74 years | 23 | 22.3% |
| Age 75 years and up | 46 | 44.7% |
| Educational Level-Some high school through advanced college degree | 103 | 100% |
| Median Educational level | Some college | N/A |
| On warfarin 3-12 months | 12 | 11.7% |
| On warfarin 1-2 years | 12 | 11.7% |
| On warfarin 3-5 years | 23 | 22.3% |
| On warfarin >5 years | 56 | 54.4% |
| Atrial Fibrillation | 27 | 26.2% |
| Valve replacement | 20 | 19.4% |
| Stroke/Stroke Prevention | 7 | 6.8% |
| DVT | 3 | 2.9% |
| Other heart conditions | 22 | 21.4% |
| Other clotting disorders | 24 | 23.3% |

Continued on next page

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| Precision | A study was conducted and the precision of duplicates for capillary blood results was calculated for both trained users and healthcare professionals. The following results were obtained: | | | | | | | | | | | | | | | |
|-----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| | User Results Professional Results N 296 308 Mean 2.47 2.45 SD 0.135 0.101 CV 5.47 4.12 | | | | | | | | | | | | | | | |
| | This study shows that trained users are able to obtain results that are as precise as those obtained by healthcare professionals trained in the use of the CoaguChek XS Plus System. | | | | | | | | | | | | | | | |

______________________________________________________________________________________________________________________________________________________________________________

:

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

### 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

Roche Diagnostics c/o Ms. Jennifer Tribbett Regulatory Program Manager 9115 Hague Road Indianapolis, Indiana 46250

**S 2000**

Re: k092940

Trade/Device Name: CoaguChek XS Plus PST System Regulation Number: 21 CFR 864.7550 Regulation Name: Prothrombin Time Test Regulatory Class: Class II Product Code: GJS Dated: January 26, 2010 Received: January 27, 2010

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 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

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Page 2 - Ms. Jennifer Tribbett

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 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

()

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Reena Philip

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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# Indication for Use

#### 510(k) Number (if known): K092940

## Device Name: CoaguChek XS Plus System for Patient Self-Testing

Indication For Use:

The CoaguChek XS Plus System measures blood-clotting time for people who are taking warfarin anticoagulation medications. The CoaguChek XS Plus System uses blood from a fingerstick. The system is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.

Prescription Use XXX (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Lenker
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K092940