(29 days)
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.
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).
Here's a breakdown of the acceptance criteria and study information for the CoaguChek XS Plus System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state "acceptance criteria" as a separate, quantified set of thresholds for each performance metric. Instead, it presents performance characteristics (e.g., accuracy, precision) of the new CoaguChek XS Plus System and compares them directly to the predicate device (CoaguChek XS System) to demonstrate substantial equivalence. The implication is that the performance of the new device is comparable to, or as good as, the predicate device.
| Performance Metric | Acceptance Criteria (Implied: Comparable to Predicate) | CoaguChek XS Plus System Performance | Predicate Device (CoaguChek XS) Performance |
|---|---|---|---|
| Accuracy (Venous Blood vs. Lab Reference) | Comparable to Predicate | N = 811Slope = 1.090Intercept = -0.2Correlation = 0.974 | N = 710Slope = 1.034Intercept = -0.02Correlation = 0.974 |
| Accuracy (Capillary Blood vs. Lab Reference) | Comparable to Predicate | N = 822Slope = 1.075Intercept = -0.1Correlation = 0.972 | N = 700Slope = 1.006Intercept = 0.032Correlation = 0.971 |
| Whole Blood Precision (Venous) | Comparable to Predicate | N = 399Mean INR = 2.32SD = 0.046CV = 2.00 | N = 357Mean INR = 2.59SD = 0.06CV = 2.42 |
| Whole Blood Precision (Capillary) | Comparable to Predicate | N = 399Mean INR = 2.26SD = 0.077CV = 3.39 | N = 344Mean INR = 2.59SD = 0.11CV = 4.35 |
| Control Precision (Level 1) | Comparable to Predicate | N = 538Mean INR = 1.18SD = 0.04CV = 3.37 | N = 54Mean INR = 1.20SD = 0.01CV = 1.1 |
| Control Precision (Level 2) | Comparable to Predicate | N = 535Mean INR = 2.95SD = 0.12CV = 4.10 | N = 54Mean INR = 2.49SD = 0.06CV = 2.3 |
| Hematocrit Range | Not significantly affect test results for 25-55% | Does not significantly affect test results for 25-55% | Same |
| Bilirubin | No significant effect up to 30 mg/dL | No significant effect up to 30 mg/dL | Same |
| Triglyceride (Lipemic samples) | No significant effect up to 500 mg/dL | No significant effect up to 500 mg/dL | Same |
| Hemolysis | No significant effect up to 1000 mg/dL | No significant effect up to 1000 mg/dL | Same |
| Heparin | Unaffected up to 0.8 U/mL | Unaffected up to 0.8 U/mL | Same |
| Low Molecular Weight Heparin | Insensitive up to 2 IU anti-factor Xa activity/mL | Insensitive up to 2 IU anti-factor Xa activity/mL | Same |
| Measuring Range | 0.8 to 8.0 INR | 0.8 to 8.0 INR | Same |
2. Sample Size Used for the Test Set and Data Provenance
- Accuracy (Venous Blood): N = 811
- Accuracy (Capillary Blood): N = 822
- Whole Blood Precision (Venous): N = 399
- Whole Blood Precision (Capillary): N = 399
- Control Precision (Level 1): N = 538
- Control Precision (Level 2): N = 535
Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. Given the nature of a 510(k) submission for a medical device that measures PT, these are typically prospective clinical studies conducted in a controlled environment to evaluate immediate device performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document refers to "lab reference" for accuracy studies. This implies that standard laboratory methods for Prothrombin Time testing were used as the gold standard. However, it does not specify the number or qualifications of experts involved in performing these reference tests or establishing the ground truth. It's likely that certified medical laboratory technologists or similar professionals performed these reference tests.
4. Adjudication Method for the Test Set
Not applicable. This device measures a quantitative value (INR). Adjudication methods like 2+1 or 3+1 are typically used for qualitative or subjective assessments where multiple readers might interpret findings, for example, in image-based diagnostics. For quantitative measurements compared to a lab reference, such adjudication is not generally needed.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The CoaguChek XS Plus System is a device designed for quantitative measurement of prothrombin time, not for subjective interpretation by multiple readers like an imaging device. Therefore, the concept of human readers improving with or without AI assistance is not directly applicable in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the studies reported are standalone performance studies of the device. The "System Performance Characteristics" section reports the accuracy and precision of the CoaguChek XS Plus System itself, comparing its measurements to a "lab reference" or evaluating its internal consistency. This is the device's inherent performance without human interpretation influencing the final reported value beyond the act of operating the device and performing the test.
7. The Type of Ground Truth Used
The ground truth used for accuracy studies was a "lab reference." This indicates that the device's PT/INR measurements were compared against results obtained from established, likely hospital- or clinical laboratory-based reference methods for Prothrombin Time determination. This would typically involve trained technicians using calibrated laboratory instruments.
8. The Sample Size for the Training Set
The document does not provide information about a "training set" or its sample size. This is typical for a 510(k) submission for a device like the CoaguChek XS Plus, which is primarily an analytical measurement device. The device's underlying technology (electrochemical detection of thrombin activity) is well-established, and its "software" is focused on measurement processing and user interface features, rather than learning from a large dataset in the way a machine learning algorithm would. The "measurement software" is stated to be identical to the predicate, suggesting it's not a new algorithm "trained" on data.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or applicable in the context of this device's development as described, there is no information on how its ground truth would have been established. If any internal development iterations involved data, it would likely be against reference lab methods to ensure the electrochemical principle and measurement algorithms were correctly implemented.
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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 Diagnostics9115 Hague RdIndianapolis IN 46250(317) 521-3723 |
| 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:CoaguChek XS |
|---|---|---|
| General features | ||
| Intended Use | Intended for use by professional healthcareproviders for quantitative prothrombintime testing for the monitoring of warfarintherapy. The system uses fresh capillary ornon-anticoagulated venous whole blood. | Same |
| Fundamental Technology | Electrochemical technology withamperometric (electric current) detectionof thrombin activity | Same |
| Sample Type | Capillary whole blood or non-anticoagulated venous whole blood | Same |
| Sample Volume | The blood drop must be a minimum of 10µL | Same |
| Test Strip | CoaguChek XS PT TestReference number: 04625315160 | Same |
| Onboard control | Built into every test strip | Same |
| External quality control | CoaguChek XS PT Controls are availableas optional external controls | Same |
| System Performance Characteristics | ||
| Hematocrit Range | Hematocrit ranges between 25 – 55% donot significantly affect test results | Same |
| Bilirubin | Bilirubin up to 30 mg/dL have nosignificant effect on test results | Same |
| Triglyceride | Lipemic samples containing up to 500mg/dL of triglycerides do not significantlyeffect on test results | Same |
| Hemolysis | Hemolysis up to 1000mg/dL have nosignificant effect on test results | Same |
| Heparin | Test results are unaffected by heparinconcentrations up to 0.8 U/mL. | Same |
| Low Molecular WeightHeparin | The CoaguChek XS PT Test is insensitiveto low molecular weight heparins(LMWH) up to 2 IU anti-factor Xaactivity/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: CoaguChekXS Plus System | Predicate Device: CoaguChekXS System |
|---|---|---|
| General features | ||
| Strip lot identification | Handled automatically by meterusing barcode reader andinformation on test strip code chip | Handled manually |
| Memory Capacity | • 500 test results with date, time,patient ID, operator ID• 60 code chip records | • 100 test results withdate and time• No code chip recordsmaintained |
| Quality Control (QC)LockoutControl Target values | If QC results fail, the operator islocked from performing a test.Lot-specific target valuesprovided on QC code chip | Not availableNo QC code chip; lot -specificvalues found on value sheet |
| Hardware modifications and features | ||
| Components | Three:• Handheld Basic Module(HBM)• Measurement Module(MM)• Barcode Reader (BR) | One:• Measurement Module(MM) |
| Handheld Basic Module(HBM) | An additional component whichprovides the power managementof the AC-adapter or rechargeablebatteries and houses all the datamanagement features including• IR module for datatransfer to external device• Beeper• Codekey connectors (fortest strip and control)• On/off button | No HBM.Peripheral functions locateddirectly on MM• IR module is on MM• Beeper is on MM• Codekey connector found onMM• on/off button on MM |
| Measurement Module(MM) | Converts raw signals from test strip into final PT result.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.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 communicationswitch | Can switch between POCT andICI | Not present |
| QC handling | QC measurement, results,lockouts handled in data manager | Not handled in software |
| Patient ID | Software allows for entry of aPatient ID | Not available |
| User ID | Software allows for the entry of aUser (Operator) ID | Not available |
| Administrator ID | Software allows for the entry ofan Administrator ID | Not available |
| User Interface | Text-enhanced icon-based userinterface | Icon-based user interface |
| Language | 12 languages can be selected | Not available |
| HBM software features | • Boot process and software updates• Driver for communication between internal components• Power management• Display software• Driver for clock and interrupt• Watchdog for configuration, powermodes | No HBM |
| System Performance Characteristics | ||
| Accuracy compared tolab reference | Venous Blood:N = 811Slope = 1.090Intercept = -0.2Correlation = 0.974 | Venous Blood:N = 710Slope = 1.034Intercept = -0.02Correlation = 0.974Capillary Blood:N = 700Slope = 1.006Intercept = 0.032Correlation = 0.971 |
| Capillary Blood:N = 822Slope = 1.075Intercept = -0.1Correlation = 0.972 | ||
| Whole Blood Precision | Venous Blood:N = 399Mean INR = 2.32SD = 0.046CV = 2.00 | Venous Blood:N = 357Mean INR = 2.59SD = 0.06CV = 2.42 |
| Capillary Blood:N = 399Mean INR = 2.26SD = 0.077CV = 3.39 | Capillary Blood:N = 344Mean INR = 2.59SD = 0.11CV = 4.35 | |
| Control Precision | Level 1N = 538Mean INR = 1.18SD = 0.04CV = 3.37 | Level 1N = 54Mean INR = 1.20SD = 0.01CV = 1.1 |
| Level 2N = 535Mean INR = 2.95SD = 0.12CV = 4.10 | Level 2N = 54Mean INR = 2.49SD = 0.06CV = 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 (301) 594-3084. 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 (800) 638-2041 or (240) 276-3150, 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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§ 864.7750 Prothrombin time test.
(a)
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).(b)
Classification. Class II (performance standards).