Search Results
Found 1 results
510(k) Data Aggregation
(269 days)
The CoaguChek® Vantus System measures an INR (International Normalized Ratio) based on a prothrombin time (PT) response to monitor the effect of a therapy with vitamin K antagonists by using the CoaguChek XS PT test strips. The CoaguChek Vantus System uses fresh capillary whole blood from a finger stick.
The system is intended for properly selected and suitable trained users on the prescription of the treating doctor.
Users should be stabilized on anticoagulation with vitamin K antagonists for at least 6 weeks prior to single patient self-testing with the CoaguChek Vantus System.
The CoaguChek Vantus System is intended for single patient self-testing only for adults, age 22 years and older.
The CoaguChek Vantus consists of a handheld meter and associated test strips.
The CoaguChek Vantus meter is a small handheld instrument intended for the quantitative measurement of INR (International Normalized Ratio) based on a prothrombin time (PT) response, by using a single electrochemical test strip. It is designed for ease of use and is intended for patient self-testing only.
The CoaguChek XS PT Test strip contains a lyophilized reagent in dried form). The reactive components of this reagent consist of thromboplastin and a peptide substrate. When a sample is applied, thromboplastin activates coagulation, which leads to the formation of thrombin. At the same time, the meter starts to measure the time. The enzyme thrombin cleaves the peptide substrate, generating an electrochemical signal. Depending on the time elapsed when it first appears, this signal is then converted by means of an algorithm into customary coagulation units and the result is displayed.
The document describes the CoaguChek Vantus System, a device for measuring INR (International Normalized Ratio) based on prothrombin time (PT) response to monitor the effect of vitamin K antagonist therapy. It uses fresh capillary whole blood from a finger stick and is intended for single patient self-testing for adults aged 22 years and older, who have been stabilized on anticoagulation for at least 6 weeks.
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state "acceptance criteria" in a table format with pass/fail results for each criterion. However, it presents various performance study results for the CoaguChek Vantus System, comparing it against the predicate device (CoaguChek XS System) and a reference laboratory analyzer (Sysmex CA-1500). The implication is that meeting these performance benchmarks supports substantial equivalence.
Here's a summary of the reported device performance from various studies:
| Performance Characteristic | Acceptance Criteria (Implied/Benchmark) | Reported Device Performance (CoaguChek Vantus System) |
|---|---|---|
| Measuring Range (INR) | Not explicitly stated as acceptance criteria, but defines operational range. | 0.8 to 6.0 INR |
| Repeatability (CV%) | Not explicitly stated as acceptance criteria, but low CV indicates good repeatability. | ** 3.5 - 4.5 INR:** Mean 4.0 INR, SD 0.12 INR, CV 3.2% |
| > 4.5 - 6.0 INR: Mean 4.9 INR, SD 0.07 INR, CV 1.5% | ||
| Reproducibility (Overall CV%) | Not explicitly stated as acceptance criteria, but low CV indicates good reproducibility. | Control Level 1 (1.32 INR): 4.0% |
| Control Level 2 (2.79 INR): 4.2% | ||
| Control Level 3 (5.85 INR): 4.0% | ||
| Control Level 4 (3.39 INR): 3.2% | ||
| Method Comparison vs. Predicate (CoaguChek XS System) | Not explicitly stated, but typically a slope close to 1, intercept close to 0, and high Pearson r are desired. | All Sites (N=207): |
| Slope: 1.00 (95% CI: 1.00, 1.03) | ||
| Intercept: 0.1 (95% CI: 0.1, 0.1) | ||
| Pearson r: 0.99 | ||
| Method Comparison vs. Reference System (Sysmex CA-1500 w/ Dade Innovin) | Not explicitly stated, but typically a slope close to 1, intercept close to 0, and high Pearson r are desired. | All Sites (N=200): |
| Slope: 0.98 (95% CI: 0.93, 1.03) | ||
| Intercept: 0.1 (95% CI: 0.0, 0.3) | ||
| Pearson r: 0.91 | ||
| Expected Values / Reference Range (Healthy Subjects) | N/A (establishing a normal range) | 95% of INRs ranged between 0.9 - 1.1 for healthy subjects not on anticoagulation therapy. |
| Factor Sensitivity | Verifies specific factor levels that do not significantly affect test results. | Factor II |
Ask a specific question about this device
Page 1 of 1