COAGUCHEK XS PRO SYSTEM
Device Facts
| Record ID | K093460 |
|---|---|
| Device Name | COAGUCHEK XS PRO SYSTEM |
| Applicant | Roche Diagnostics |
| Product Code | GJS · Hematology |
| Decision Date | Mar 18, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7750 |
| Device Class | Class 2 |
Intended Use
The CoaguChek® XS Pro 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
Portable coagulation monitoring system; monitors prothrombin time (PT) in patients on oral anticoagulant therapy. Input: 8μL fresh capillary or non-anticoagulated venous whole blood applied to test strip. Principle: Amperometric detection of thrombin; thromboplastin activates coagulation cascade; thrombin cleaves peptide substrate to generate electrical signal. Output: INR value displayed on handheld device. Used by professional healthcare providers in clinical settings. Features embedded barcode reader for automatic strip lot identification; onboard quality control (OBC) assesses strip integrity; QC lockout prevents testing if QC fails. Stores up to 1000 test results and 500 QC results. Benefits: Rapid, point-of-care monitoring of warfarin therapy; automated quality control ensures result reliability.
Clinical Evidence
Bench testing only. Precision/reproducibility demonstrated using 120 meters; results showed <2% CV and <2% bias for controls, <3% CV and <2% bias for blood samples. Method comparison study (n=1,037) across five hematocrit levels (25-55%) and three test strip lots confirmed acceptable correlation with predicate. Interference testing (bilirubin, lipemia, hemolysis, heparin) showed no significant interference. No clinical studies performed.
Technological Characteristics
Electrochemical test system. Reagent: Human recombinant thromboplastin and peptide substrate. Components: Handheld Basic Module (power/data), Measurement Module (signal conversion), embedded barcode reader. Connectivity: Data storage for 1000 INR/500 QC results. Power: AC adapter or rechargeable batteries. Calibration: Traceable to WHO International Reference Preparations (rTF/95).
Indications for Use
Indicated for professional healthcare providers monitoring warfarin therapy in patients requiring prothrombin time testing 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 XS Plus System (k071041)
Related Devices
- K060978 — COAGUCHEK XS SYSTEM · Roche Diagnostics · Aug 11, 2006
- K062925 — COAGUCHEK XS SYSTEM · Roche Diagnostics Corp. · Jan 29, 2007
Submission Summary (Full Text)
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K093460
MAR 1 8 2010
# 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: Jennifer Tribbett<br><br>Date Prepared: March 15, 2010 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Device name | Proprietary name: CoaguChek® XS Pro System<br>Common name: Prothrombin time test<br>Classification name: Prothrombin time test |
| 3) Predicate device | The CoaguChek XS Pro System is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, the CoaguChek XS Pro System is a modification of the previously cleared CoaguChek XS Plus System (K071041). |
| 4) Device Description | The CoaguChek XS Pro System represents a modification of the CoaguChek XS Plus System to incorporate an embedded barcode scanner. The unmodified device was cleared for use under premarket notification K071041.<br><br>The intended use of the modified device, as described in its labeling, has not changed as a result of the modification(s) described in this 510(k).<br><br>The fundamental scientific technology of this device has not changed as a result of the modification(s) described in this 510(k). |
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| 5) Intended Use The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoguChek<br>XS PT Test strips) quantitatively determines prothrombin time ("PT"), using<br>capillary blood or whole blood from a vein (nonanticoagulated venous whole<br>blood). It is indicated for use by healthcare professionals. The system is<br>ideally suited to monitor coagulation values in people who are taking oral<br>anticoagulation medication (vitamin K antagonists. VKAs). |
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<sup>6)</sup> Similarities The table below indicates the similarities between the CoaguChek XS Plus System and the CoaguChek XS Pro System.
| Topic | CoaguChek XS Plus System<br>(predicate: unmodified device) | CoaguChek XS Pro System<br>(modified device) |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | General Features | |
| Intended use | Intended for use by professional<br>healthcare providers for quantitative<br>prothrombin time testing for the<br>monitoring of warfarin therapy. | The CoaguChek XS Pro System<br>(CoaguChek XS Pro meter and<br>CoguChek XS PT Test strips)<br>quantitatively determines<br>prothrombin time (“PT”), using<br>capillary blood or whole blood from<br>a vein (nonanticoagulated venous<br>whole blood). It is indicated for use<br>by healthcare professionals. The<br>system is ideally suited to monitor<br>coagulation values in people who<br>are taking oral anticoagulation<br>medication (vitamin K antagonists,<br>VKAs). |
| Fundamental technology | Electrochemical technology with<br>amperometric (electric current) detection<br>of thrombin activity | Same |
| Sample type | Fresh capillary or non-anticoagulated<br>venous whole blood | Same |
| Test strip | The CoaguChek XS PT Test Strip | Same |
| Onboard control | Built into every strip and recognized by<br>the meter | Same |
| External quality control | CoaguChek XS PT Controls are available<br>as optional external controls | Same |
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| Topic | CoaguChek XS Plus System<br>(predicate: unmodified device) | CoaguChek XS Pro System<br>(modified device) |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| System Performance Characteristics | | |
| Measuring range | 0.8 – 8.0 INR | Same |
| Hemotocrit range | Hematocrit ranges between 25 – 55%<br>have no significant effect on 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 have no<br>significant effect on test results. | Same |
| Hemolysis | Hemolysis up to 1000 mg/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 |
| Topic | CoaguChek XS Plus System<br>(predicate: unmodified device) | CoaguChek XS Pro System<br>(modified device) |
| System Performance Characteristics | | |
| Low Molecular Weight<br>Heparin | The CoaguChek XS PT Test is<br>insensitive to low molecular weight<br>heparins (LMWH) up to 2IU anti-factor<br>Xa activity/mL | Same |
| Accuracy compared to<br>the reference | <b>Venous Blood:</b><br>N=811<br>Slope= 1.090<br>Intercept = -0.2<br>Correlation = 0.974<br><b>Capillary Blood:</b><br>N = 822<br>Slope = 1.075<br>Intercept = -0.1<br>Correlation = 0.972 | Same |
| Whole Blood Precision | <b>Venous Blood:</b><br>N = 399<br>Mean INR = 2.32<br>SD = 0.046<br>CV = 2.00<br><b>Capillary Blood:</b><br>N = 399<br>Mean INR = 2.26<br>SD = 0.077<br>CV = 3.39 | Same |
| Control Precision | <b>Level 1:</b><br>N = 538<br>Mean INR = 1.18<br>SD = 0.04<br>CV = 3.37<br><br><b>Level 2:</b><br>N = 535<br>Mean INR = 2.95<br>SD = 0.12<br>CV = 4.10 | Same |
| Topic | CoaguChek XS Plus System<br>(predicate: unmodified device) | CoaguChek XS Pro System<br>(modified device) |
| <b>Hardware</b> | | |
| Measurement module<br>(Measurement engine) | Converts raw signals from test strip into<br>final PT result. | Same<br>Measurement Module has not been<br>modified |
| Handheld Basic Module | Provides the power management of the<br>AC-adapter or rechargeable batteries and<br>houses all the data management features. | Same<br>Handheld Basic Module has not<br>been modified |
| <b>Software</b> | | |
| Code chip function | Code chip information is stored in meter<br>to identify test strip and liquid control<br>information. | Same |
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#### The table below indicates the modified features of the CoaguChek XS Pro System. 7) Differences
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| Topic | CoaguChek XS Plus System<br>(predicate: unmodified device) | CoaguChek XS Pro System<br>(modified device) |
|---------------------------------------------------|------------------------------------------------------------|----------------------------------------------------------------------|
| General Features | | |
| Note: The test strip itself has not been modified | | |
| Capillary sample volume | Blood drop must be minimum 10 µl | Blood drop must be minimum 8 µl |
| Code Chip Modifications | | |
| Blood application time | 120 seconds | 180 seconds |
| Operating temperature | 18° - 32 °C | 15° - 32 °C |
| | Hardware | |
| Barcode Scanner | External Barcode Scanner | Integrated Barcode Scanner |
| Display | LED Display | TFT Display |
| Size | 185 x 98 x 42 mm | 231 x 97 x 43 mm |
| Weight | 311 g (without batteries) | 350 g (without batteries) |
| | Software | |
| Memory | 500 INR results, 500 QC results | 1000 INR results, 500 QC results |
| Display | User interface shows images/icons | Upgraded display shows<br>images/icons and more descriptive<br>text. |
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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 depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
### 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
Re: k093460
Trade/Device Name: Coaguchek XS Pro System
Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin time test Regulatory Class: Class II Product Code: GJS Dated: February 8, 2010 Received: February 12, 2010
MAR 1 8 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 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device 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
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Page 2 – Ms. Jennifer Tribbett
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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
ie m chan
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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## Indications for Use Form
510(k) Number (if known): K093460
CoaguChek XS Pro System Device Name:
Indications For Use:
The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (nonanticoagulated venous whole blood). It is indicated for use by healthcare professionals. The system is ideally suited to monitor coagulation values in people who are taking oral anticoagulation medication (vitamin K antagonists, VKAs).
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)
GENERAL CERTIFICATE OF SECONDARY E
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) KC9346.0
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