(149 days)
The Lp(a)-Latex SEIKEN Assay kit is an in vitro diagnostic test for the quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma samples with Hitachi 917 analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests.
The Lp(a)-Latex SEIKEN Assay Kit is a latex in vitro diagnostic immunoassay for the quantitative determination of Lipoprotein (a) in human serum and plasma. Antigen in the sample binds to the specific anti-Lp(a) antibody, which has been adsorbed to latex particles, and agglutinates. The agglutination is detected as an absorbance change when read on Hitachi 917 analyzer, with the magnitude of the change being proportional to the quantity of Lp(a) in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentrations.
Here's a breakdown of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for correlation coefficient, sensitivity, or precision. Instead, it presents the results of the performance studies and concludes that these findings demonstrate the device's "robustness and substantial equivalence to the predicate device."
However, we can infer the implied acceptance criteria from the reported performance, which demonstrates that the device's performance is acceptable for its intended use, especially in comparison to the predicate device.
| Performance Metric | Implied Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (Lp(a)-Latex SEIKEN Assay) |
|---|---|---|
| Correlation Coefficient (vs. Predicate) | High correlation (e.g., >0.90) | r = 0.919 |
| Precision (Medium Control %CV) | Low %CV (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).