(258 days)
The CoaguChek S System is used for the quantitative determination of prothrombin time (PT) in fresh capillary or venous whole blood by professional health care providers.
The CoaguChek S System is used for the quantitative determination of prothrombin time (PT) in fresh capillary or venous whole blood by professional health care providers.
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. People 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 CoaguChek Test Strip uses a modified version of this method.
The test strip, used as directed with the CoaguChek S 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.
The provided 510(k) summary focuses on demonstrating substantial equivalence of the CoaguChek S System to its predicate device, the CoaguChek System (K930454). The study presented primarily involves a comparison of performance characteristics rather than establishing specific acceptance criteria and then proving the device meets them with a standalone study. However, we can infer acceptance criteria based on the comparison to the predicate.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for the new device in a typical pass/fail format. Instead, it compares the performance of the CoaguChek S System to the predicate CoaguChek System. The implicit acceptance criteria are that the new device's performance should be comparable to or within acceptable limits of the predicate. We will present the performance characteristics as a comparison.
| Performance Characteristic | Implicit Acceptance Criteria (Comparable to Predicate) | CoaguChek S System Performance |
|---|---|---|
| Strip Related Claims (Same as Predicate) | ||
| Factor Sensitivity | Factors II, V, VII, and X | Factors II, V, VII, and X |
| Hematocrit Range | 32% - 52% | 32% - 52% |
| Reportable Range | 0.6 - 8.0 INR | 0.6 - 8.0 INR |
| Reagent Stability | 20 months | 20 months |
| Device Performance Claims | ||
| Precision (Between-Day Control Mean CV) | Level 1: 12.6 sec 3.7% CV (Predicate) | Level 1: 14.9 sec 4.4% CV |
| Level 2: 23.2 sec 4.1% CV (Predicate) | Level 2: 20.6 sec 5.2% CV | |
| Precision (Blood Sample) | Capillary: 17.2 sec 2.2% CV (Predicate) | Capillary: 19.4 sec 2.2% CV |
| Venous: 17.6 sec 1.9% CV (Predicate) | Venous: 19.3 sec 2.7% CV | |
| Accuracy (Venous Whole Blood vs. MLA 700/1600) | Y=0.859x + 1.3, R=0.985 (Predicate) | Y=0.935x + 0.004, R=0.904 |
Study Proving Acceptance:
The study presented is a comparative performance study between the CoaguChek S System and its predicate, the CoaguChek System.
2. Sample Size Used for the Test Set and Data Provenance:
- For Accuracy (Venous Whole Blood):
- Test Set Size: N=219
- Data Provenance: Not explicitly stated, but based on the nature of medical device testing for FDA submission, it would typically be prospective clinical or laboratory data collected in a controlled environment. The country of origin is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable in the context of this submission. The "ground truth" for the accuracy study is established by a reference laboratory method (MLA 700/1600), not by human expert consensus or adjudication.
4. Adjudication Method for the Test Set:
- Not applicable. The ground truth is established by a reference laboratory instrument (MLA 700/1600), so no human adjudication process is described or appears relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This device is an automated diagnostic coagulation system, not an imaging device requiring human reader interpretation or assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
- Yes, the performance characteristics provided (precision and accuracy) are standalone performance metrics for the CoaguChek S System (algorithm/device only). The accuracy is measured by comparing the device's results to a reference method (MLA 700/1600), quantifying the device's direct measurement capability.
7. The Type of Ground Truth Used:
- The ground truth for the accuracy study (the primary performance evaluation) was established by a reference laboratory instrument/method, specifically the MLA 700/1600 for Prothrombin Time.
8. The Sample Size for the Training Set:
- The document does not explicitly mention a "training set" or its sample size. For an IVD device like this, the development process would involve internal validation and optimization, but specific training set sizes for an algorithm (in the sense of AI/ML) are not detailed here, as the device relies on a chemical-mechanical principle ("dancing particle") rather than a complex AI model requiring extensive training data.
9. How the Ground Truth for the Training Set Was Established:
- As a training set is not explicitly mentioned, the method for establishing its ground truth is also not detailed. Device development typically involves rigorous in-house testing and validation against established reference methods or known controls, which serve as the "ground truth" during development and calibration, but these are not formally presented as a "training set" in this 510(k) summary.
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.