(74 days)
The Genzyme N-geneous™ HDL Cholesterol Kit, is a two-reagent homogenous method for use in the direct quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum and plasma.
The Genzyme N-geneous™ HDL Cholesterol Kit, is a two-reagent homogenous method for use in the direct quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum and plasma. The first readent contains a mixture of polymers and polvanions that bind to the sufface of low-density lipoproteins (LDL), very low-density lipoproteins (VLDL) and chylomicrons. These complexed lipoproteins are stabilized, even in the presence of detergent which is added as part of the second reagent, together with cholesterol enzymes. HDL particles, on the other hand, are not stabilized by the polymers and polvanions and become solubilized by the detergent. Consequently, only the HDL cholesterol is subject to cholesterol measurement.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to prove the device meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a dedicated section. However, based on the comparative performance studies, the implicit acceptance criteria for equivalence seem to be a high correlation coefficient and a regression equation demonstrating close agreement with the predicate methods. For precision, the acceptance criteria would be low %CV values, indicating good reproducibility.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (N-geneous™ HDL Cholesterol Kit) |
|---|---|---|
| Comparative Performance | ||
| Correlation Coefficient (r) vs. Phosphotungstic Acid | High (e.g., >0.90, typically >0.95 for good agreement) | 0.96 |
| Regression Equation vs. Phosphotungstic Acid | Slope close to 1, intercept close to 0 | y = 0.81x + 7.82 |
| Correlation Coefficient (r) vs. CDC Method | High (e.g., >0.90, typically >0.95 for good agreement) | 0.96 |
| Regression Equation vs. CDC Method | Slope close to 1, intercept close to 0 | y = 1.01x - 3.39 |
| Precision (Within-Run) | ||
| %CV (Low HDL) | Low %CV (e.g., |
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.