(49 days)
Reagents: For the direct, quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum or plasma. Calibrators: For the calibration of the N-geneous™ LDL Cholesterol assay in serum or plasma. Controls: To monitor the performance of Genzyme LDL Cholesterol Reagents.
The Genzyme N-geneous™ LDL Cholesterol Reagent is a two-reagent homogeneous method for the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum and plasma. The principle of the test is based upon a unique detergent which selectively solubilizes only the non-L.DL lipoproteins, allowing them to be removed by cholesterol enzymes prior to the LDL cholesterol reaction. The LDL particles remain intact. The hydrogen peroxide produced by the reaction of the enzymes with the released cholesterol is consumed by a peroxidase reaction with 4-aminoantipyrine. yielding a colorless product. A second detergent, capable of releasing LDL cholesterol molecules, is added. The enzyme reaction with LDL cholesterol in the presence of the coupler produces color which is proportional to the amount of LDL cholesterol in the sample.
The Genzyme N-geneous™ LDL Cholesterol Reagent is a two-reagent homogeneous method for the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum and plasma. The study aimed to demonstrate substantial equivalence to existing predicate devices: Direct LDL Cholesterol Immunoseparation Reagent and β-Quantification methods.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for "substantial equivalence" are implicitly derived from the comparative performance studies against the reference methods. The device's performance metrics (slope, intercept, correlation coefficient, mean, standard deviation, mean difference, mean percent difference) were compared to those of the predicate devices. Precision was also evaluated.
| Metric | Acceptance Criteria (Implied for Substantial Equivalence) | N-geneous™ LDL vs. β-Quantification (n=54) | N-geneous™ LDL vs. Direct LDL (n=92) |
|---|---|---|---|
| Comparative Studies | |||
| Slope | Close to 1.0 | 0.96 | 0.94 |
| Intercept | Close to 0.0 | 3.02 | 4.46 |
| Correlation Coefficient (r) | High (e.g., >0.95 for strong correlation) | 0.96 | 0.97 |
| Mean Difference (mg/dL) | Close to 0.0 | -2.62 | -2.81 |
| Mean Percent Difference (%) | Close to 0.0 | -1.9% | -2.0% |
| Precision Studies | Within-Run %CV | Between-Run %CV | |
| LDL |
§ 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.