(66 days)
For quantitative prothrombin time testing in fresh capillary blood with the CoaguChek System by properly selected and suitably trained patients or their caregivers on the prescription or other order of the treating doctor.
The CoaguChek PT.S Test is for quantitative prothrombin time testing in fresh capillary blood with the CoaguChek System by properly selected and suitably trained patients or their caregivers on the prescription or other order of the treating doctor.
Blood coagulation is one of the body's protective responses. Blood clots (thrombi) form as a direct response to vessel injury, preventing excessive loss of blood. Certain disease conditions require oral anticoagulants, sometimes known as blood thinners. Warfarin, sometimes known as Coumadin®, is a commonly used anticoagulant. Patients on warfarin must be carefully monitored to ensure the anticoagulant level is maintained in the therapeutic range. One method for monitoring the anticoagulant level is by using the one-stage Prothrombin Time (PT) Test. The PT.S test strip uses a modified version of this method.
The PT.S test strip, used as directed with the CoaguChek monitor, will accurately measure blood PT values. After placing a drop of fresh whole blood on the test strip, the blood is drawn into the reaction chamber and mixed with reagents that cause coagulation to begin. In the test strip, tiny iron particles are mixed with the sample. Alternating magnetic fields cause the iron particles to move within the sample. The endpoint is reached when the blood clot stops the iron particles from moving. The PT result is then displayed by the monitor.
Here's a breakdown of the acceptance criteria and study information for the CoaguChek™ PT•S Test for Prothrombin Time Self-Testing, based on the provided text:
Acceptance Criteria and Device Performance
| Metric | Acceptance Criteria (Predicate Device K962571) | Reported Device Performance (CoaguChek™ PT•S Test) |
|---|---|---|
| Accuracy | Slope = 0.973, Intercept = 0.05, Correlation Coefficient = 0.966 | Slope = 1.011, Intercept = -0.03, Correlation Coefficient = 0.978 |
| Precision (Patient) | N = 1070, Mean = 3.81, SD = 0.39, CV = 10.31 | N = 841, Mean = 2.33, SD = 0.15, CV = 6.45 |
| Precision (Professional) | N = 40, Mean = 3.78, SD = 0.35, CV = 9.30 | N = 140, Mean = 2.35, SD = 0.14, CV = 5.79 |
| Verified Clinical Range | 0.6 - 8.0 INR | 0.8 - 8.0 INR |
Note: The document presents the predicate device's performance as the benchmark for "acceptance criteria" through substantial equivalence. The new device's performance is listed alongside for comparison.
Study Information
The provided document describes a substantial equivalence comparison study against a predicate device (K962571), rather than a standalone clinical trial with explicitly defined "acceptance criteria" and "study proving it." The information below is extracted based on the nature of this submission.
2. Sample Size and Data Provenance:
- Test Set Sample Size:
- Accuracy: 84 observations
- Precision (Patient Results): 841 observations
- Precision (Professional Results): 140 observations
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the device is for "patient self-testing" and "professional results," implying data collected from actual patient and professional use, likely in a clinical setting. The submission date (March 2003) and 510(k) approval (May 2003) suggest the data was collected retrospectively to support the submission or as part of a prospective study leading up to it.
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable/Not specified. The ground truth for prothrombin time (PT) tests is typically established by laboratory reference methods, not by expert consensus on visual review or interpretation. The document compares the device's measurements to another established method.
4. Adjudication Method:
- Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 typically apply to studies where human interpretation (e.g., of medical images) requires consensus. For a quantitative diagnostic test like PT, the "ground truth" is a numerical value derived from a reference method, not subject to human adjudication in that manner.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, typically in imaging diagnostics. The CoaguChek™ PT•S Test is a quantitative diagnostic test performed by a device, not a human reader interpreting complex information.
6. Standalone (Algorithm Only) Performance:
- Yes, the performance data presented (accuracy and precision) represents the standalone performance of the CoaguChek™ PT•S Test strip and CoaguChek monitor system. The device produces a direct numerical result (PT/INR) without human interpretation in the loop. The "professional results" and "patient results" for precision indicate testing done by different user groups, but both represent the device's output.
7. Type of Ground Truth Used:
- The ground truth is quantitative prothrombin time (PT) values obtained from a reference method or legally marketed predicate device (CoaguChek System K962571). The accuracy data, which compares the new device's slope, intercept, and correlation coefficient, suggests a comparison against an existing, validated PT measurement method.
8. Sample Size for the Training Set:
- Not applicable/Not specified. The CoaguChek™ PT•S Test is a diagnostic test based on a chemical reaction and mechanical detection (iron particle movement), not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not specified, as there is no "training set" for this type of device.
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K03084/5
510(k) Summary
MAY 22 2003
| 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.P.O. Box 50457Indianapolis, IN 46250-0457Contact Person: Jennifer TribbettDate Prepared: March 14, 2003 |
| 2) Device name | Proprietary name: CoaguChek™ PT•S Test for Prothrombin Time Self-TestingCommon name: Prothrombin time testClassification name: Prothrombin time test |
| 3) Predicate device | The Roche Diagnostics PT•S test strip and controls on the CoaguChek System for Patient Self-Testing are substantially equivalent to other products in commercial distribution intended for Patient Self-Testing. Most notably, the system is substantially equivalent to the currently marketed CoaguChek System for Prothrombin Time Self-Testing (K962571). |
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510(k) Summary, Continued
The CoaguChek PT.S Test is for quantitative prothrombin time testing in 4) Device Description fresh capillary blood with the CoaguChek System by properly selected and suitably trained patients or their caregivers on the prescription or other order of the treating doctor.
Blood coagulation is one of the body's protective responses. Blood clots (thrombi) form as a direct response to vessel injury, preventing excessive loss of blood. Certain disease conditions require oral anticoagulants, sometimes known as blood thinners. Warfarin, sometimes known as Coumadin®, is a commonly used anticoagulant. Patients on warfarin must be carefully monitored to ensure the anticoagulant level is maintained in the therapeutic range. One method for monitoring the anticoagulant level is by using the one-stage Prothrombin Time (PT) Test. The PT.S test strip uses a modified version of this method.
The PT.S test strip, used as directed with the CoaguChek monitor, will accurately measure blood PT values. After placing a drop of fresh whole blood on the test strip, the blood is drawn into the reaction chamber and mixed with reagents that cause coagulation to begin. In the test strip, tiny iron particles are mixed with the sample. Alternating magnetic fields cause the iron particles to move within the sample. The endpoint is reached when the blood clot stops the iron particles from moving. The PT result is then displayed by the monitor.
For quantitative prothrombin time testing in fresh capillary blood with the 5) Intended use CoaguChek System by properly selected and suitably trained patients or their caregivers on the prescription or other order of the treating doctor.
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510(k) Summary, Continued
- Similarities to and differences from predicate device
| Topic | CoaguChek System for ProthrombinTime Self-Testing(K962571) | CoaguChek System forProthrombin Time Self-Testingwith the PT•S Test Strip andControls |
|---|---|---|
| Intended Use | For quantitative prothrombin time (PT)testing in fresh capillary blood with theCoaguChek System by properly selectedand suitably trained patients or theircaregivers on the prescription or otherorder of the treating doctor. | Same |
| Test Principle | After placing a drop of fresh capillaryblood on the test strip, the blood drawninto the reaction chamber and mixedwith reagents that cause coagulation tobegin. In the test strip, tiny iron particlesare mixed with the sample. Alternatingmagnetic fields cause the iron particlesto move within the sample. The test iscomplete when the blood clot stops theiron particles from moving. The PTresult is then displayed by the monitor. | Same |
| Reagents | Each test strip contains rabbitthromboplastin, stabilizers andpreservatives | Each test strip contains humanrecombinant thromboplastin,stabilizers, a heparin neutralizingagent and preservatives |
| InternationalSensitivity Index | ISI is approximately 2 | ISI is approximately 1 |
| Storage andStability | You may store strips at roomtemperature for up to 60 days, thenrefrigerate until the "Use By" date. | (Improved) You may store strips atroom temperature for up to 90 days,then refrigerate until the "Use By"date. |
| Topic | CoaguChek System for ProthrombinTime Self-Testing(K962571) | CoaguChek System forProthrombin Time Self-Testingwith the PT•S Test Strip andControls |
| Storage andStability | Remove one test strip foil pouch fromthe refrigerator. Allow the sealed pouchto set at room temperature for at leastfive minutes before opening for testing. | (Improved) A warm up period of 5minutes is not necessary with thePT•S test strip. |
| Storage andStability | Use the test strip within four minutesafter opening the foil pouch. | (Improved) Use the test strip withinten minutes after opening the foilpouch |
| Quality ControlRecommendation | Two levels of control should be testedupon receipt of each test strip cartonand each day of use. | Same |
| Verified ClinicalRange | 0.6 - 8.0 INR | 0.8 - 8.0 INR |
| Accuracy | N = 315 observationsSlope = 0.973Intercept = 0.05Correlation Coefficient = 0.966 | N = 84 observationsSlope = 1.011Intercept = -0.03Correlation Coefficient = 0.978 |
| Precision | Patient ResultsProfessional Results | Patient ResultsProfessional Results |
| N1070Mean3.81SD0.39CV10.31 | N841Mean2.33SD0.15CV6.45 | |
| N40Mean3.78SD0.35CV9.30 | N140Mean2.35SD0.14CV5.79 |
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New System vs. Predicate System -Continued-
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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Jennifer Tribbett Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
MAY 22 2003
Re: K030845
Trade/Device Name: CoaguChek™ PT•S Test for Prothrombin Time Self-Testing Regulation Number: 21 CFR § 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: II Product Code: GJS Dated: March 14, 2003 Received: March 17, 2003
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. Iisting 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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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K030845 510(k) Number (if known):
CoaguChek™ PT•S Test for Prothrombin Time Self-Testing Device Name:
Indications for Use:
For quantitative prothrombin time testing in fresh capillary blood with the CoaguChek System by properly selected and suitably trained patients or their caregivers on the prescription or other order of the treating doctor.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Quxeline Bautista
(Division Sign-Q Division of Clinical Laboratory Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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).