(162 days)
The CoaguChek XS Plus System measures blood-clotting time for people who are taking warfarin anticoagulation medications. The CoaguChek XS Plus System uses blood from a fingerstick. The system is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.
The CoaguChek XS Plus System was previously cleared for professional use under premarket notification K071041. This premarket notification is being submitted to obtain clearance for patient self-testing.
Here's a breakdown of the acceptance criteria and the study details for the CoaguChek® XS Plus System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states "Acceptance Criteria" under each performance characteristic evaluated in the study.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (N=307) | Device Meets Criteria? |
|---|---|---|---|
| Accuracy | High correlation between self-tester and healthcare professional results. Specifically, a correlation coefficient (r) indicating a strong linear relationship and a regression line close to ideal (slope = 1, intercept = 0). | N = 307, Slope = 1.000, Intercept = 0.0, Correlation Coefficient (r) = 0.963. The regression equation is Y = 0.000 + 1.000 * X. | Yes (Correlation Coefficient = 0.963 is very high, and regression parameters are ideal). |
| Precision | Self-tester results should be as precise as healthcare professional results. (Evaluated by comparing SD and CV values for duplicate capillary blood results). | Self-Tester: N=296, Mean=2.47, SD=0.135, CV=5.47. Professional: N=308, Mean=2.45, SD=0.101, CV=4.12. | Yes (The CV for self-testers (5.47) is comparable to or slightly higher than, but still close to, professionals (4.12), indicating acceptable precision for self-testing). |
| Consistency Over Time | Self-tester results should be consistent over time. | "This study also demonstrated that self-tester results are consistent over time." (No specific quantitative criteria or data provided in the excerpt for this. It's a general statement about the study's finding.) | Yes (Based on the general statement in the summary, implied by the overall success of the study. No specific data provided within this document portion to quantify this.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Accuracy Test Set: 307 patients (for the comparison between self-tester and healthcare professional results).
- Sample Size for Precision Test Set: 296 for self-testers, 308 for professionals.
- Data Provenance: The study was conducted by Roche Diagnostics. It was a prospective clinical study involving four visits to a clinical site, with subjects self-testing in a home setting for up to 8 weeks, and also having 3 scheduled visits to their study site to collect user vs. technician data. The demographic information for the trained users who completed all visits (103 patients) lists "Age range (years) 34-86", with educational levels ranging from "Some high school through advanced college degree." The specific country of origin is not explicitly stated, but Roche Diagnostics is based in Indianapolis, IN, USA, and the 510(k) submission is to the FDA, suggesting a US-based study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for comparison was established by "healthcare professionals trained in the use of the CoaguChek XS Plus System" (referred to as "technician" in the regression analysis). The exact number of individual healthcare professionals is not specified, nor are their specific qualifications (e.g., number of years of experience, specific medical degrees). However, the study involved a comparison against "healthcare professionals," implying a standard of reference for accurate PT/INR measurement.
4. Adjudication Method
The document does not explicitly describe an adjudication method for conflicting results. The study compares results from "trained users" (self-testers) against "healthcare professionals." It's implied that the healthcare professional's measurement serves as the reference or "ground truth" against which the self-tester's performance is compared, rather than a conciliation process between discrepant readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is focused on the performance of a device used by patients (self-testers) compared to its use by healthcare professionals, not on how an AI system changes human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this study is inherently a standalone performance evaluation of the device. The "algorithm" here is the entire CoaguChek XS Plus System. The study evaluated its performance when used by two distinct "classes" of users: self-testers and healthcare professionals. The objective was to demonstrate the device's accuracy and precision in the hands of self-testers, without a human-in-the-loop AI component being assessed. It compares the device's performance under different user conditions.
7. The Type of Ground Truth Used
The ground truth for the test set was established by measurements obtained by trained healthcare professionals using the same CoaguChek XS Plus System. This serves as the reference standard for evaluating the accuracy of results obtained by self-testers.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" in the context of machine learning. The study describes training for the users of the device (self-testers) rather than training for an algorithm. The patient demographics section describes the characteristics of the study subjects who were trained and whose data was collected.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for an algorithm in the machine learning sense, this question is not applicable. The "training" described in the document refers to the face-to-face training provided to the study subjects (self-testers) on how to use the CoaguChek XS Plus System, not the training of an AI model with ground truth data.
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Kosaayd
MAR - 5 2010
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
|---|---|
| 1) Submittername, address,contact | Roche Diagnostics Corporation9115 Hague Rd.Indianapolis, IN 46250Contact Person: Jennifer TribbettDate Prepared: September 22, 2009 |
| 2) Device name | Proprietary name: CoaguChek® XS Plus SystemCommon name: Prothrombin time testClassification name: Prothrombin time test |
| 3) Predicatedevice | The Roche Diagnostics CoaguChek XS Plus System (patient self-testing) issubstantially equivalent in materials, design and function to other productsthat measure prothrombin time INR in human blood. Most notably, it issubstantially equivalent to the Roche Diagnostics CoaguChek XS PlusSystem (professional). In fact, it is identical in materials, design and functionto the CoaguChek XS Plus System (professional) except the labeling has beenmodified and validated for patient self-testing.The labeling created for the CoaguChek XS Plus System (patient self-testing)is substantially equivalent in format and content to the CoaguChek XSSystem (patient self-testing). |
| 4) DeviceDescription | The CoaguChek XS Plus System was previously cleared for professional useunder premarket notification K071041.This premarket notification is being submitted to obtain clearance for patientself-testing. |
| 5) Intended Use | The CoaguChek XS Plus System measures blood-clotting time for peoplewho are taking warfarin anticoagulation medications. The CoaguChek XSPlus System uses blood from a fingerstick. The system is intended forproperly selected and suitably trained users or their caregivers on theprescription or other order of the treating doctor. |
| 6) Comparison toPredicate Device | The following characteristics have been previously submitted, reviewedand cleared under the premarket notification for the CoaguChek XS PlusSystem (K071041): |
| • Factor Sensitivity | |
| • Heparin Sensitivity | |
| • Hematocrit Effect | |
| • Interfering Substances | |
| • Normal Range | |
| • Measuring Range | |
| • Test Strip Stability | |
| • Integrated (on-board) Quality Control | |
| • Instrument Failsafes | |
| • Calibration | |
| • Software Development | |
| These 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. Followingface-to-face training, the subjects self-tested in the home setting for up to 8weeks. The subjects also had 3 scheduled visits to their study site tocollect user vs. technician data. |
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The study results successfully demonstrated that self-trained subjects can obtain results that are equivalent to healthcare professionals. This study also demonstrated that self-tester results are consistent 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 results obtained bytrained users with those obtained by healthcareprofessionals, when both were using the CoaguChek XSPlus System. The correlation was very good, as indicatedby the following statistics: N = 307, Slope = 1.000,Intercept = 0.0 and Correlation Coefficient = 0.963. Thisstudy shows that trained users are able to obtain resultsthat are as accurate as those obtained by healthcareprofessionals trained in the use of the CoaguChek XS PlusSystem. |
Passing-Bablock Regression analysis (Subject vs. Technician) (Overall)
Image /page/2/Figure/3 description: This image is a scatter plot that compares Subject INR to Technician INR. The x-axis represents Technician INR, and the y-axis represents Subject INR, both ranging from 0 to 7. The plot includes a regression line and the equation Y = 0.000 + 1.000 * X, with a sample size of 307. The correlation coefficient (r) is 0.9632, and t = 0.8970.
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| Study UserDemographics | A clinical study was conducted by Roche Diagnostics,consisting of four visits to the clinical site. Informedconsent and randomization occurred at visit 1.Testing began at visit 2. 103 patients completed allvisits. The following table outlines the demographicinformation for the trained users who completed allvisits. |
|---|---|
| ---------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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| Demographic | Number | Percent |
|---|---|---|
| Total number of users | 103 | 100% |
| Males | 57 | 55.3% |
| Females | 46 | 44.7% |
| Age range (years) | 34-86 | N/A |
| Mean age (years) | 69 | N/A |
| Age 65-69 years | 20 | 19.4% |
| Age 70-74 years | 23 | 22.3% |
| Age 75 years and up | 46 | 44.7% |
| Educational Level-Some high school through advanced college degree | 103 | 100% |
| Median Educational level | Some college | N/A |
| On warfarin 3-12 months | 12 | 11.7% |
| On warfarin 1-2 years | 12 | 11.7% |
| On warfarin 3-5 years | 23 | 22.3% |
| On warfarin >5 years | 56 | 54.4% |
| Atrial Fibrillation | 27 | 26.2% |
| Valve replacement | 20 | 19.4% |
| Stroke/Stroke Prevention | 7 | 6.8% |
| DVT | 3 | 2.9% |
| Other heart conditions | 22 | 21.4% |
| Other clotting disorders | 24 | 23.3% |
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| Precision | A study was conducted and the precision of duplicates for capillary blood results was calculated for both trained users and healthcare professionals. The following results were obtained: | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| User Results Professional Results N 296 308 Mean 2.47 2.45 SD 0.135 0.101 CV 5.47 4.12 | ||||||||||||||||
| This study shows that trained users are able to obtain results that are as precise as those obtained by healthcare professionals trained in the use of the CoaguChek XS Plus System. |
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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 eagle or bird symbol, with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
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
S 2000
Re: K092940
Trade/Device Name: CoaguChek XS Plus PST System Regulation Number: 21 CFR 864.7550 Regulation Name: Prothrombin Time Test Regulatory Class: Class II Product Code: GJS Dated: January 26, 2010 Received: January 27, 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
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Page 2 - Ms. Jennifer Tribbett
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (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 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,
()
10%
Reena Philip
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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Indication for Use
510(k) Number (if known): K092940
Device Name: CoaguChek XS Plus System for Patient Self-Testing
Indication For Use:
The CoaguChek XS Plus System measures blood-clotting time for people who are taking warfarin anticoagulation medications. The CoaguChek XS Plus System uses blood from a fingerstick. The system is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.
Prescription Use XXX (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Lenker
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092940
§ 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).