(121 days)
N Latex Lp(a) Reagent is an in vitro diagnostic test for the quantitative determination of Lipoprotein(a) [Lp(a)] in human serum or plasma. N Latex Lp(a) aids in the diagnosis of disorders of lipid (fat) metabolism and helps to identify persons at risk from cardiovascular disease in specific populations when used in conjunction with clinical evaluation.
Polystyrene latex particles coated with specific antibodies to human Lp(a) are agglutinated when mixed with samples containing Lp(a). The intensity of scattered light in the BN™ Systems depends on the Lp(a) concentration in the sample. The concentration can therefore be determined by comparison with dilutions of a standard of known concentration.
Acceptance Criteria and Device Performance Study for N Latex Lp(a) Reagent
This report details the acceptance criteria and the study conducted to demonstrate the performance of the N Latex Lp(a) Reagent, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Correlation | Strong positive correlation (e.g., r > 0.90) with a legally marketed predicate device. Slope close to 1, y-intercept close to 0. | Correlation coefficient: 0.96 (with Beckman Coulter Array® System LPA assay) |
| Y-intercept: -0.005 | ||
| Slope: 0.92 (Passing-Bablok) | ||
| Precision (Intra-assay) | Low coefficient of variation (CV%) for repeated measurements within the same assay (e.g., |
§ 866.5600 Low-density lipoprotein immunological test system.
(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).