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510(k) Data Aggregation
(123 days)
COAGUCHEK XS SYSTEM
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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(123 days)
COAGUCHEK XS SYSTEM
The CoaguChek XS 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.
The CoaguChek XS is a 3rd generation CoaguChek meter which measures prothrombin time in fresh capillary or non-anticoagulated venous whole blood samples. The CoaguChek XS System incorporates many of the perspectives shared by FDA during reviews of our previous systems, including but not limited to integrated quality control and a blood application area that is outside the meter. The CoaguChek XS System includes a meter and CoaguChek XS PT test strips. Each box of test strips has its own code chip that you insert into the meter. The code chip contains important information about the test strips such as their expiration date and lot number. The meter and test strips work together to provide a safe and reliable system for testing blood-clotting time.
Here's a breakdown of the acceptance criteria and study information for the CoaguChek® XS System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document compares the CoaguChek XS System to its predicate, the CoaguChek S System, across various performance characteristics. While explicit "acceptance criteria" (i.e., predefined thresholds for success) are not formally stated with numerical targets, the comparison table implicitly defines them by demonstrating performance that is either equivalent to or improved upon the predicate device.
| Performance Characteristic | Acceptance Criteria (Implicit - based on predicate or improved performance) | CoaguChek XS System Reported Performance |
|---|---|---|
| Bilirubin Interference | No significant effect up to 20 mg/dL (predicate) | No significant effect up to 30 mg/dL |
| Hemolysis Interference | No significant effect up to 500 mg/dL (predicate) | No significant effect up to 1000 mg/dL |
| Triglycerides Interference | No significant effect up to 500 mg/dL (predicate) | No significant effect up to 500 mg/dL |
| Hematocrit Range | Not significantly affected between 32 - 52% (predicate) | Not significantly affected between 25 - 55% |
| Heparin Insensitivity | Unaffected up to 2.0 U/mL (predicate) | Unaffected up to 0.8 U/mL* |
| Low Molecular Weight Heparin Insensitivity | Insensitive up to 1 IU anti-factor Xa activity/mL (predicate) | Insensitive up to 2 IU anti-factor Xa activity/mL |
| Capillary Accuracy (vs. Lab Analyzer Plasma) | Correlation (R) of 0.965 (predicate) | Correlation (R): 0.971 (N=700) |
| Venous Accuracy (vs. Lab Analyzer Plasma) | Correlation (R) of 0.970 (predicate) | Correlation (R): 0.974 (N=710) |
| Whole Blood Precision (Venous) | CV = 4.43 (predicate) | CV = 2.42 (N=357) |
| Whole Blood Precision (Capillary) | CV = 7.19 (predicate) | CV = 4.35 (N=344) |
*Note: The heparin insensitivity for CoaguChek XS is lower than the predicate. This is a difference from the predicate, not necessarily an "improvement" in this specific metric. However, the overall device was found substantially equivalent.
2. Sample Size for Test Set and Data Provenance
- Capillary Accuracy: N=700 (combined across all sites)
- Venous Accuracy: N=710 (combined across all sites)
- Whole Blood Precision (Venous): N=357
- Whole Blood Precision (Capillary): N=344
- Data Provenance: The document states that precision was determined from samples collected at "three external sites" for the CoaguChek XS and "five external sites" for the predicate venous blood and "four external sites" for the predicate capillary blood. The specific country of origin is not specified, but the context of an FDA submission suggests studies likely conducted in or compliant with standards in North America or internationally accepted clinical study practices. It refers to "fresh capillary or non-anticoagulated venous whole blood samples," implying prospective collection for the purpose of the study.
3. Number of Experts and Qualifications for Ground Truth
This information is not provided in the given text. The "ground truth" for Prothrombin Time (PT) tests here is a comparison against a laboratory-based reference method, not an expert assessment of images or clinical diagnoses. The reference methods mentioned are:
- Capillary Accuracy: Sysmex Analyzer using Dade Innovin (ISI = 1.02)
- Venous Accuracy: Sysmex Analyzer using Dade Innovin (ISI = 1.02)
- Predicate device comparison: MLA 900 using Ortho Recombiplastin (ISI = 1.03)
These are recognized automated laboratory coagulation analyzers, not human experts.
4. Adjudication Method for the Test Set
This information is not applicable as the ground truth is established by a laboratory reference analyzer, not human reviewers requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable as the device is a diagnostic testing system (measuring prothrombin time), not an imaging device requiring human interpretation for diagnosis. Therefore, there's no "human readers improve with AI vs without AI assistance" scenario.
6. Standalone (Algorithm Only) Performance
Yes, this study primarily assesses the standalone performance of the CoaguChek XS System by comparing its results directly to established laboratory reference methods. The device itself is an automated system, and its output (INR values) is the direct result of its internal algorithm and electrochemical technology.
7. Type of Ground Truth Used
The ground truth used is comparison to a laboratory-based reference method (Sysmex Analyzer using Dade Innovin) for Prothrombin Time (PT) and International Normalized Ratio (INR) measurements. This is considered a highly objective standard for in vitro diagnostic devices like this.
8. Sample Size for the Training Set
The provided text does not specify the sample size for a training set. Given the context of a 510(k) summary, the focus is on performance validation rather than the details of algorithm development (which would typically involve training data). The "CoaguChek XS is a 3rd generation CoaguChek meter," suggesting iterative development, but specific training set details are omitted.
9. How Ground Truth for Training Set was Established
This information is not provided in the document as training set details are not described.
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