(123 days)
The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin® or warfarin. The CoaguChek XS System 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. Users should be stabilized on anticoagulation medications such as Coumadin® or warfarin prior to self-testing with the CoaguChek XS System.
The CoaguChek XS is a 3rd generation Roche Diagnostic's CoaguChek meter which was cleared for professional use under premarket notification K060978.
This premarket notification is being submitted to obtain clearance for patient self-testing.
This document describes the CoaguChek® XS System for patient self-testing, a device intended to measure blood-clotting time (PT-INR) for individuals on anticoagulation medications like Coumadin® or warfarin. The 510(k) submission (K062925) aims to clear the professional-use CoaguChek XS System (cleared under K060978) for patient self-testing.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes studies validating the accuracy and precision of the CoaguChek XS System for self-testing by patients. The "acceptance criteria" are implied by the conclusions drawn from these studies (e.g., "correlation was very good," "able to obtain results that are as accurate as those obtained by healthcare professionals").
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Accuracy | Self-trained patient results are equivalent to healthcare professional results. | N = 258 Slope = 1.00 Intercept = 0.0 Correlation Coefficient = 0.974 "This study shows that self-trained patients are able to obtain results that are as accurate as those obtained by healthcare professionals trained in the use of the CoaguChek XS meter." |
| Precision | Self-trained patient results are equivalent to healthcare professional results regarding within-run precision (duplicates). | Patient Results: N=222, Mean=2.55, SD=0.132, CV=5.19 Professional Results: N=257, Mean=2.50, SD=0.135, CV=5.38 (assuming "₹ :38" is a typo for 5.38 based on surrounding values and context) "This study shows that self-trained patients are able to obtain results that are as precise as those obtained by healthcare professionals trained in the use of the CoaguChek XS meter." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Accuracy Study: N = 258 (patients who self-tested and were compared to healthcare professionals).
- Sample Size for Precision Study: N = 222 (patients for patient results) and N = 257 (professionals for professional results).
- Data Provenance: The study was an "external user study" conducted as the system is intended to be used. Subjects self-tested "in the home setting for up to 8 weeks." They also had "3 scheduled visits to their study site to collect user vs. technician data as well as user vs. reference method." This indicates a prospective study conducted in a real-world setting (home) and clinical sites. The country of origin is not explicitly stated, but the submission is to the U.S. FDA by Roche Diagnostics Corporation in Indianapolis, IN, suggesting the study likely took place in the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. However, it indicates:
- For accuracy, self-trained patient results were compared to "those obtained by healthcare professionals using the CoaguChek XS meter." These professionals' results served as a comparator, representing an established standard.
- For precision, results from "healthcare professionals" were also used for comparison.
- Additionally, subjects had visits to "collect user vs. reference method (Dade Innovin on a Sysmex analyzer) data." The INR results from the Dade Innovin on a Sysmex analyzer would be considered a form of ground truth or reference standard.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1 consensus) for establishing the ground truth. It focuses on direct comparison between patient results, healthcare professional results, and a reference laboratory method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not explicitly described in the provided text. The study compared patient self-testing performance with healthcare professional performance and a reference method, but it was not structured as an MRMC study to determine the effect size of AI assistance on human readers. The device itself (CoaguChek XS System) is a point-of-care diagnostic device, not an AI-assisted diagnostic tool for interpretation by multiple readers in the typical MRMC sense.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The CoaguChek XS System is not an algorithm that operates in isolation. It's a device that requires a human user (either a patient or a healthcare professional) to perform the test. Therefore, a "standalone algorithm-only" study (without human involvement) is not applicable or described. The studies evaluate the performance of the system (device + user).
7. The Type of Ground Truth Used
The ground truth or reference standard used in the studies appears to be a combination of:
- Results obtained by healthcare professionals using the same CoaguChek XS meter.
- A "reference method": specifically, "Dade Innovin on a Sysmex analyzer." This is a laboratory-grade prothrombin time (PT) method, considered a highly reliable reference for INR measurements.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of device development or algorithm training. The studies described are performance validation studies, not studies related to machine learning model training. The "training" aspect mentioned refers to the human users (patients) undergoing "self-directed training" to use the device.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a traditional "training set" for an algorithm or machine learning model, information on how its ground truth was established is not applicable. The device validation focused on the ability of trained users (patients) to operate the device accurately and precisely, and their results were compared against established clinical and laboratory standards.
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JAN 2 9 2007
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 Corporation9115 Hague Rd.Indianapolis, IN 46250Contact Person: Luann OchsDate Prepared: January 29, 2007 |
| 2) Device name | Proprietary name: CoaguChek® XS SystemCommon name: Prothrombin time testClassification name: Prothrombin time test |
| 3) Predicate device | The Roche Diagnostics CoaguChek XS System (patient self-testing) is substantially equivalent in materials, design and function to other products that measure prothrombin time INR in human blood. Most notably, it is substantially equivalent to the Roche Diagnostics CoaguChek XS System (professional). In fact, it is identical in materials, design and function to the CoaguChek XS System (professional) except the labeling has been modified and validated for patient self-testing. |
| 4) Device Description | The CoaguChek XS is a 3rd generation Roche Diagnostic's CoaguChek meter which was cleared for professional use under premarket notification K060978.This premarket notification is being submitted to obtain clearance for patient self-testing. |
| 5) Intended Use | The CoaguChek XS PT test strips are part of the CoaguChek XSSystem. The CoaguChek XS System measures blood-clotting time for peoplewho are taking anticoagulation medications such as Coumadin® orwarfarin. The CoaguChek XS System uses blood from a finger stick. Thesystem is intended for properly selected and suitably trained users or theircaregivers on the prescription or other order of the treating doctor. Usersshould be stabilized on anticoagulation medications such as Coumadin® orwarfarin prior to self-testing with the CoaguChek XS System. |
| 6) Comparison toPredicate Device | The following characteristics have been previously submitted, reviewedand cleared under the premarket notification for the CoaguChek XSSystem (K060978):•Factor Sensitivity•Heparin Sensitivity•Hematocrit Effect•Interfering Substances•Normal Range•Measuring Range•Test Strip Stability•Integrated Quality Control•Instrument Failsafes•Calibration•Software DevelopmentThese characteristics are not impacted by the new user population.The use of the system by self-testers was validated by an external userstudy that was conducted as the system is intended to be used. Followingself-directed training, the subjects self-tested in the home setting for up to8 weeks. The subjects also had 3 scheduled visits to their study site tocollect user vs. technician data as well as user vs. reference method (DadeInnovin on a Sysmex analyzer) data.The study results successfully demonstrated that self-trained subjects canobtain results that are equivalent to healthcare professionals and to thereference method. This study also demonstrated that self-tester results areconsistent 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 resultsobtained by self-trained patients with those obtainedby healthcare professionals using the CoaguChek XSmeter. The correlation was very good, as indicated bythe following statistics: N = 258, Slope = 1.00,Intercept = 0.0 and Correlation Coefficient = 0.974.This study shows that self-trained patients are able toobtain results that are as accurate as those obtained byhealthcare professionals trained in the use of theCoaguChek XS meter. | |||
| Precision | A study was conducted and the precision of duplicatesfor capillary blood results was calculated for bothself-trained patients and healthcare professionals.The following results were obtained: | |||
| Patient ResultsProfessional Results | ||||
| N | 222 | 257 | ||
| Mean | 2.55 | 2.50 | ||
| SD | 0.132 | 0.135 | ||
| CV | 5.19 | ર :38 | ||
| This study shows that self-trained patients are able toobtain results that are as precise as those obtained byhealthcare professionals trained in the use of theCoaguChek XS meter. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. 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
ROCHE Diagnostics Corp. C/O Jennifer Tribbett 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250
JAN 2 9 2007
Re: K062925
Trade/Device Name: CoaguChek® XS System for Patient Self-testing Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: Class II Product Code: GJS Dated: September 27, 2006 Received: September 28, 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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
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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 Part 801), please contact the Office of Compliance at (240) 276-0450. 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/industry/support/index.html.
Sincerely yours,
Robert A. Becker, Jr.
Robert L. Becker, Jr., MD, PhI 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- |< 0 6 2 9 2 5
CoaguChek® XS System for Patient Self-Testing Device Name:
Indications For Use:
The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin® or warfarin. The CoaguChek XS System 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. Users should be stabilized on anticoagulation medications such as Coumadin® or warfarin prior to self-testing with the CoaguChek XS System.
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)
Suphine Bautista
Division Sign
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K062925
§ 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).