COAGUCHEK XS PLUS SYSTEM

K071041 · Roche Diagnostics · GJS · May 11, 2007 · Hematology

Device Facts

• Record ID: K071041
• Device Name: COAGUCHEK XS PLUS SYSTEM
• Applicant: Roche Diagnostics
• Product Code: GJS · Hematology
• Decision Date: May 11, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7750
• Device Class: Class 2

Intended Use

Intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The system uses fresh capillary or non-anticoagulated venous whole blood.

Device Story

Portable coagulation monitoring system for professional use in clinical settings. Inputs: 10 uL fresh capillary or non-anticoagulated venous whole blood applied to test strip. Principle: Amperometric detection of thrombin activity. System comprises Handheld Basic Module (HBM), Measurement Module (MM), and Barcode Reader (BR). HBM manages power, data, and IR communication; MM converts raw signals to PT results using identical software to predicate. BR enables automatic strip lot identification via 2D barcode. Output: Quantitative PT result (INR) displayed on screen. Features include QC lockout, memory for 500 results, and patient/operator ID entry. Healthcare providers use results to adjust warfarin therapy, potentially improving patient anticoagulation management.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements (21 CFR 820.30) to assess impact of hardware and software modifications.

Technological Characteristics

Handheld diagnostic device; includes barcode reader, base unit, and QC control chip. Software updated for enhanced UI and QC handling. Memory capacity increased. QC lock-out feature implemented.

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).

Submission Summary (Full Text)

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K07104/

MAY 1 1 2007

## 510(k) Summary – CoaguChek XS Plus System

| 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 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name, address, contact | Roche Diagnostics<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone] |
| | Contact person: Theresa A. Bush |
| | Date prepared: April 11, 2007 |
| Device Name | Proprietary name: CoaguChek® XS Plus System |
| | Common name: Prothrombin time test |
| | Classification name: Prothrombin time test |
| Device Description | The CoaguChek XS Plus system is a portable coagulation monitoring system to monitor prothrombin time (PT) in patients receiving oral anticoagulant therapy. The system uses the amperometric detection of thrombin in the blood sample. A test strip is used to determine a PT value from 10 uL of whole blood. Onboard quality control is available on every test strip and the system also features an optional external quality control material (CoaguChek XS PT Control). |
| Intended use | Intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The system uses fresh capillary or non-anticoagulated venous whole blood. |
| Predicate Device | The Roche Diagnostics CoaguChek XS Plus System is substantially equivalent to to the previously cleared CoaguChek XS System (K060978). |
| Similarities | The table below indicates the similarities between the CoaguChek XS Plus System and the CoaguChek XS System. |

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| Feature/Claim | Modified Device: CoaguChek XS Plus | Predicate Device:<br>CoaguChek XS |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| | General features | |
| Intended Use | Intended for use by professional healthcare<br>providers for quantitative prothrombin<br>time testing for the monitoring of warfarin<br>therapy. The system uses fresh capillary or<br>non-anticoagulated venous whole blood. | Same |
| Fundamental Technology | Electrochemical technology with<br>amperometric (electric current) detection<br>of thrombin activity | Same |
| Sample Type | Capillary whole blood or non-<br>anticoagulated venous whole blood | Same |
| Sample Volume | The blood drop must be a minimum of 10<br>µL | Same |
| Test Strip | CoaguChek XS PT Test<br>Reference number: 04625315160 | Same |
| Onboard control | Built into every test strip | Same |
| External quality control | CoaguChek XS PT Controls are available<br>as optional external controls | Same |
| | System Performance Characteristics | |
| Hematocrit Range | Hematocrit ranges between 25 – 55% do<br>not significantly affect test results | Same |
| Bilirubin | Bilirubin up to 30 mg/dL have no<br>significant effect on test results | Same |
| Triglyceride | Lipemic samples containing up to 500<br>mg/dL of triglycerides do not significantly<br>effect on test results | Same |
| Hemolysis | Hemolysis up to 1000mg/dL have no<br>significant effect on test results | Same |
| Heparin | Test results are unaffected by heparin<br>concentrations up to 0.8 U/mL. | Same |
| Low Molecular Weight<br>Heparin | The CoaguChek XS PT Test is insensitive<br>to low molecular weight heparins<br>(LMWH) up to 2 IU anti-factor Xa<br>activity/mL | Same |
| Measuring Range | 0.8 to 8.0 INR | Same |

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| Modifications | The following table lists the modified features of the CoaguChek XS Plus System. |
|---------------|----------------------------------------------------------------------------------|
|---------------|----------------------------------------------------------------------------------|

| Feature/Claim | Modified Device: CoaguChek<br>XS Plus System | Predicate Device: CoaguChek<br>XS System |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General features | | |
| Strip lot identification | Handled automatically by meter<br>using barcode reader and<br>information on test strip code chip | Handled manually |
| Memory Capacity | • 500 test results with date, time,<br>patient ID, operator ID<br>• 60 code chip records | • 100 test results with<br>date and time<br>• No code chip records<br>maintained |
| Quality Control (QC)<br>Lockout<br>Control Target values | If QC results fail, the operator is<br>locked from performing a test.<br>Lot-specific target values<br>provided on QC code chip | Not available<br>No QC code chip; lot -specific<br>values found on value sheet |
| Hardware modifications and features | | |
| Components | Three:<br>• Handheld Basic Module<br>(HBM)<br>• Measurement Module<br>(MM)<br>• Barcode Reader (BR) | One:<br>• Measurement Module<br>(MM) |
| Handheld Basic Module<br>(HBM) | An additional component which<br>provides the power management<br>of the AC-adapter or rechargeable<br>batteries and houses all the data<br>management features including<br>• IR module for data<br>transfer to external device<br>• Beeper<br>• Codekey connectors (for<br>test strip and control)<br>• On/off button | No HBM.<br>Peripheral functions located<br>directly on MM<br>• IR module is on MM<br>• Beeper is on MM<br>• Codekey connector found on<br>MM<br>• on/off button on MM |
| Measurement Module<br>(MM) | Converts raw signals from test strip into final PT result.<br>Same measurement software as XS, ensuring same test processes and result Strip chamber cover with modified blue cover Same printed circuit board with differences in assembled components for peripheral functions: Additional connector to HBM Beeper, codekey connectors, IR module and on/off buttons are on the HBM, not on the MM Set and memory buttons are accessible via touch screen; not as separate keys | Contains measurement software for generation of PT result from raw signal Contains strip chamber cover Houses peripheral functions such as beeper, code chip connector, IR-module, and three buttons (on/off, memory, setup) |
| Barcode Reader (BR) | Separate board with camera and electronics; enables automatic Strip Lot Identification by reading 2D barcode on test strip and comparing to codekey | No bar code reader |
| Software modifications and features | | |
| Measurement oftware | IDENTICAL to measurement software on XS | Converts raw signal into PT result |
| Barcode reader software | Software communicates with barcode reader and responds to barcodes | No barcode reader |
| Code chip (aka codekey) software | Codekey information stored in data manager; transferred to measurement manager Codekey for liquid QC | General codekey handling in measurement module.<br>No codekey for liquid QC. |
| Errorhandling | Handled in data manager with additional features | Handled in measurement module |
| Connection to Host | Infrared via POCT/ICI communication | Infrared via ICI communication |
| Infrared communication<br>switch | Can switch between POCT and<br>ICI | Not present |
| QC handling | QC measurement, results,<br>lockouts handled in data manager | Not handled in software |
| Patient ID | Software allows for entry of a<br>Patient ID | Not available |
| User ID | Software allows for the entry of a<br>User (Operator) ID | Not available |
| Administrator ID | Software allows for the entry of<br>an Administrator ID | Not available |
| User Interface | Text-enhanced icon-based user<br>interface | Icon-based user interface |
| Language | 12 languages can be selected | Not available |
| HBM software features | • Boot process and software updates<br>• Driver for communication between internal components<br>• Power management<br>• Display software<br>• Driver for clock and interrupt<br>• Watchdog for configuration, powermodes | No HBM |
| System Performance Characteristics | | |
| Accuracy compared to<br>lab reference | Venous Blood:<br>N = 811<br>Slope = 1.090<br>Intercept = -0.2<br>Correlation = 0.974 | Venous Blood:<br>N = 710<br>Slope = 1.034<br>Intercept = -0.02<br>Correlation = 0.974<br><br>Capillary Blood:<br>N = 700<br>Slope = 1.006<br>Intercept = 0.032<br>Correlation = 0.971 |
| | Capillary Blood:<br>N = 822<br>Slope = 1.075<br>Intercept = -0.1<br>Correlation = 0.972 | |
| Whole Blood Precision | Venous Blood:<br>N = 399<br>Mean INR = 2.32<br>SD = 0.046<br>CV = 2.00 | Venous Blood:<br>N = 357<br>Mean INR = 2.59<br>SD = 0.06<br>CV = 2.42 |
| | Capillary Blood:<br>N = 399<br>Mean INR = 2.26<br>SD = 0.077<br>CV = 3.39 | Capillary Blood:<br>N = 344<br>Mean INR = 2.59<br>SD = 0.11<br>CV = 4.35 |
| Control Precision | Level 1<br>N = 538<br>Mean INR = 1.18<br>SD = 0.04<br>CV = 3.37 | Level 1<br>N = 54<br>Mean INR = 1.20<br>SD = 0.01<br>CV = 1.1 |
| | Level 2<br>N = 535<br>Mean INR = 2.95<br>SD = 0.12<br>CV = 4.10 | Level 2<br>N = 54<br>Mean INR = 2.49<br>SD = 0.06<br>CV = 2.3 |

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## MAY 1 1 2007

Roche Diagnostics C/O Theresa A. Bush, PhD, RAC 9115 Hague Road Indianapolis, Indiana 46250

Re: k071041

Trade/Device Name: CoaguChek® XS Plus System Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin time test Regulatory Class: Class II Product Code: GJS Dated: April 11, 2007 Received: April 12, 2007

Dear Dr. Bush:

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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Page 2 - Theresa A. Bush, PhD, RAC

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, 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,

Sincerely yours,

Robert Zastocki

Robert L. Becker, Jr., MD, PhD 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

Ko 71041 510(k) Number (if known):

Device Name: CoaguChek XS Plus System

Indications For Use:

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

Prescription Use XXX (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 In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K071041

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Special 510(k) for CoaguChek XS Plus System. Confidential

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