COAGUCHEK XS SYSTEM

K060978 · Roche Diagnostics · GJS · Aug 11, 2006 · Hematology

Device Facts

• Record ID: K060978
• Device Name: COAGUCHEK XS SYSTEM
• Applicant: Roche Diagnostics
• Product Code: GJS · Hematology
• Decision Date: Aug 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7750
• Device Class: Class 2

Intended Use

The CoaguChek® XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The CoaguChek® XS System uses fresh capillary or non-anticoagulated venous whole blood.

Device Story

CoaguChek XS is a 3rd generation point-of-care meter for prothrombin time (PT) testing; used by professional healthcare providers to monitor warfarin therapy. Input: fresh capillary or non-anticoagulated venous whole blood applied to CoaguChek XS PT test strips. Operation: electrochemical technology with amperometric detection of thrombin activity; integrated quality control uses electrochemical signals to verify test strip integrity. Output: PT/INR results displayed on meter. System includes meter and test-specific code chips (containing lot/expiration data). Benefits: provides rapid, reliable clotting time monitoring; improved performance over optical-based predecessors; integrated quality control ensures test reliability. Healthcare providers use results to adjust warfarin dosage.

Clinical Evidence

Clinical performance was evaluated in a 361-patient study across 3 sites. Comparison against a laboratory-based Dade Innovin thromboplastin method on a Sysmex analyzer showed acceptable bias. Regression analysis for venous (n=710, r=0.974) and capillary (n=700, r=0.971) samples demonstrated strong correlation with laboratory results. Precision testing met acceptance criteria (≤4.5% INR for venous, ≤7.5% INR for capillary). Interference testing confirmed no significant impact from heparin (up to 2 u/ml), Tinzaparin/Enozaparin (up to 2 IU anti-Xa/ml), bilirubin, lipemia, or hemolysis. Normal range testing (n=121) established a reference interval of 0.9–1.1 INR.

Technological Characteristics

Electrochemical system using amperometric detection of thrombin activity. Test strips contain human recombinant tissue factor (ISI 1.0). Features integrated bi-level on-board quality control (OBC) for strip integrity monitoring. Meter includes infrared communication for data transfer and memory for 100 results. Calibrated to WHO International Reference Preparations (rTF/95).

Indications for Use

Indicated for professional healthcare providers to perform quantitative prothrombin time (PT) testing for monitoring warfarin therapy in patients using fresh capillary or non-anticoagulated venous whole blood.

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 S System (K020831)

Submission Summary (Full Text)

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K060978

AUG 】】2006

# 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 |
| | Contact Person: Jennifer Tribbett |
| | Date Prepared: April 6, 2006 |
| 2) Device name | Proprietary name: CoaguChek® XS System<br>Common name: Prothrombin time test<br>Classification name: Prothrombin time test |
| 3) Predicate<br>device | The Roche Diagnostics CoaguChek XS System is substantially equivalent to<br>other products in commercial distribution intended for similar use. Most<br>notably, it is substantially equivalent to the Roche Diagnostics CoaguChek S<br>System (K020831). |
| 4) Device<br>Description | The CoaguChek XS is a 3rd generation CoaguChek meter which measures<br>prothrombin time in fresh capillary or non-anticoagulated venous whole blood<br>samples.<br>The CoaguChek XS System incorporates many of the perspectives shared by<br>FDA during reviews of our previous systems, including but not limited to<br>integrated quality control and a blood application area that is outside the meter.<br>The CoaguChek XS System includes a meter and CoaguChek XS PT test<br>strips. Each box of test strips has its own code chip that you insert into the<br>meter. The code chip contains important information about the test strips such<br>as their expiration date and lot number. The meter and test strips work<br>together to provide a safe and reliable system for testing blood-clotting time. |

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- The CoaguChek XS System is intended for use by professional healthcare 5) Intended Use providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The CoaguChek XS System uses fresh capillary or nonanticoagulated venous whole blood.
- The CoaguChek XS System is similar to the predicate CoaguChek S 6) Similarities to predicate device System in the following items:

| Topic | Comment |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Both are intended to be used by professional healthcare<br>providers for the quantitative prothrombin time (PT) testing<br>to monitor warfarin therapy, using fresh capillary or non-<br>anticoagulated venous whole blood. |
| Measuring Range | Both systems have a measuring range of 0.8 – 8.0 INR. |
| Closed System | Both systems use instrument and reagent strips that are<br>provided by Roche and are intended to be used together. |
| Specimen collection and<br>preparation instructions | These instructions are the same for both systems. |
| Sample Volume | Both require a minimum of 10 $ $\mu$ $ L capillary blood |
| Thromboplastin | Both contain human recombinant thromboplastin, stabilizers<br>and preservatives. |
| International Sensitivity Index | Both have an ISI established as 1. |
| Calibration of results | Both systems are traceable to the WHO reference method. |

The following table lists the major differences between the CoaguChek 7) Differences from predicate device XS System and the predicate CoaguChek S System.

| Topic | CoaguChek XS System | CoaguChek S System (Predicate) |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology | Electrochemical technology with<br>amperometric (electric current)<br>detection of thrombin activity. | Dancing particle technology with<br>optical detection of thrombin activity. |
| Quality Control | On-board fully integrated quality<br>controls which use electrochemical<br>signals to detect test strip integrity. | Liquid controls and external<br>electronic quality control |
| Test Strip Dosing | Top and side dosing | Top dosing only |
| Start up | Instrument turns on with either the<br>insertion of the test strip or the push<br>of a button | Instrument turns on with the push of a<br>button |
| Memory | 100 test results with time & date | 60 test results with time & date |
| Claim | CoaguChek XS System | CoaguChek S System<br>(Predicate) |
| Bilirubin | No significant effect up to 30 mg/dL | No significant effect up to 20 mg/dL |
| Hemolysis | No significant effect up to 1000 mg/dL | No significant effect up to 500 mg/dL |
| Triglycerides | No significant effect up to 500 mg/dL | No significant effect up to 500 mg/dL |
| Hematocrit | Hematocrit ranges between 25 - 55%<br>do not significantly affect test results. | Hematocrit ranges between 32 - 52%<br>do not significantly affect test results. |
| Heparin | Unaffected by heparin concentrations<br>up to 0.8 U/mL. | Unaffected by heparin concentrations<br>up to 2.0 U/mL. |
| Low Molecular<br>Weight Heparin | Insensitive to low molecular weight<br>heparins up to 2 IU anti-factor Xa<br>activity/mL. | Insensitive to low molecular weight<br>heparins up to 1 IU anti-factor Xa<br>activity/mL. |
| Capillary<br>Accuracy<br>(All Sites) | Capillary blood on CoaguChek XS vs.<br>venous plasma on a Sysmex Analyzer<br>using Dade Innovin (ISI = 1.02)<br>N= 700<br>$y= 1.006x + 0.032$<br>Correlation: 0.971 | Capillary blood on CoaguChek S vs.<br>venous plasma on MLA 900 using<br>Ortho Recombiplastin (ISI = 1.03)<br>N= 539<br>$y= 1.150x - 0.25$<br>Correlation: 0.965 |
| Venous<br>Accuracy<br>(All Sites) | Venous Whole Blood:<br>CoaguChek XS vs. Sysmex Analyzer<br>using Dade Innovin (ISI = 1.02)<br>N= 710<br>$Y= 1.034x - 0.02$<br>Correlation: 0.974 | Venous Whole Blood:<br>CoaguChek S vs. MLA 900 using<br>Ortho Recombiplastin (ISI = 1.03)<br>N= 761<br>$Y= 1.150x - 0.24$<br>Correlation: 0.970 |
| Claim | CoaguChek XS System | CoaguChek S System |
| | | (Predicate) |
| Precision with<br>blood | Whole blood precision for venous and<br>capillary samples was determined from<br>sample duplicates collected at three<br>external sites. | Whole blood precision was<br>determined from sample duplicates at<br>five external sites for the venous<br>blood and four external sites for the<br>capillary blood. |
| | Bland Altman plots for both capillary<br>and venous blood are provided in the<br>test strip insert. | Bland Altman plots for both capillary<br>and venous blood are provided in the<br>test strip insert. |
| The following information represents<br>the data that is graphically shown by<br>the Bland Altman plots. | Venous: | The following information represents<br>the data that is graphically shown by<br>the Bland Altman plots. |
| | Venous: | Venous: |
| | N = 357<br>Mean = 2.59 INR<br>SD = 0.06<br>CV = 2.42 | N = 376<br>Mean = 2.5 INR<br>SD = 0.11<br>CV = 4.43 |
| | Capillary: | Capillary: |
| | N = 344<br>Mean = 2.59 INR<br>SD = 0.11<br>CV = 4.35 | N = 268<br>Mean = 2.1 INR<br>SD = 0.15<br>CV = 7.19 |

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#### The following chart shows a comparison of performance characteristic 8) Performance characteristics claims for the CoaguChek XS System and the CoaguChek S System.

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### Performance -Continuedcharacteristics

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its wing. 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

# AUG 1 1 2006

ROCHE DIAGNOSTICS c/o Jennifer Tribbett 9115 Hague Road Indianapolis, IN 46256

Re: k060978/S001 CoaguChek® XS System Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: Class II Product Code: GJS Dated: April 6, 2006 Received: April 10, 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 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

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

If you desire specific information about the application of labeling requirements to your device, rryou don't specific introlion and advertising of your device, please contact the Office of In of questions on the proce Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation other general information on your responsibilities under the Act from the Tou may 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,

Robert L. Betz

Robert L. Becker, Jr., MD. PMD. 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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## Indications for Use

510(k) Number (if known):

K060978

Device Name: CoaguChek® XS System

Indications For Use:

The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The CoaguChek XS System uses fresh capillary or non-anticoagulated venous whole blood.

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)

Aurghine Bautista
Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K060978