(53 days)
Coamatic® Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma using automated and microplate methods. The amount of UFH or LMWH is determined from the anti-FXa activity expressed by the [AT*Heparin] complex formed in plasma.
Coamatic® Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma using automated and microplate methods.
Here's a breakdown of the acceptance criteria and study information for the Coamatic® Heparin device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the provided document. Instead, the study aims to demonstrate "substantial equivalence in its performance" to the predicate device (IL Test™ Heparin). This is primarily assessed through correlation studies, where a slope close to 1, an intercept close to 0, and a high correlation coefficient (r) indicate substantial equivalence. Precision is also evaluated using %CV.
Therefore, the acceptance criteria are inferred from what constitutes "substantially equivalent performance" in such comparative studies.
| Performance Metric | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Comparative Studies (vs. Predicate IL Test™ Heparin) | ||
| Slope | Close to 1.00 (e.g., 0.90 to 1.10) | Range: 0.91 to 1.04 |
| Intercept | Close to 0.00 (e.g., -0.10 to 0.10) | Range: -0.01 to 0.06 |
| Correlation (r) | High (e.g., ≥ 0.95) | Range: 0.97 to 0.99 |
| Precision (Microplate Method) | ||
| Within Run %CV (UFH) | Low (e.g., |
§ 864.7525 Heparin assay.
(a)
Identification. A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).(b)
Classification. Class II (performance standards).