(186 days)
The PLAC® Test for Lp-PLA2 Activity is an enzyme assay for the in vitro quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) activity in EDTA-plasma and serum on automated clinical chemistry analyzers. Lp-PLA2 activity is to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events.
The Lp-PLA2 Activity Test Calibrators are intended to establish points of reference that are used in the determination of values in the measurement of Lp-PLA2 activity by the PLAC® Test for Lp-PLA2 Activity.
The Lp-PLA2 Activity Test Controls are intended for use as a quality control tool to monitor the performance within the clinical range of the PLAC® Test for Lp-PLA2 Activity, an enzyme assay for the quantitative determination of Lp-PLA2 activity.
The PLAC® Test for Lp-PLA2 Activity consists of the reagents, Lp-PLA2 Activity Test Calibrators and Lp-PLA2 Activity Test Controls for the measurement of Lp-PLA2 activity in EDTA-plasma or serum on automated clinical laboratory analyzers.
Lp-PLA2, in plasma or serum, hydrolyzes the sn-2 position of the substrate, 1myristoyl-2-(4-nitrophenylsuccinyl) phosphatidylcholine, producing a colored reaction product, 4-nitrophenol. The rate of formation of 4-nitrophenol is measured spectrophotometrically for 8.5 minutes and the Lp-PLA2 activity is calculated from the rate of change in absorbance. A set of five Lp-PLA2 calibrators is used to generate a standard curve fit of change in absorbance versus Lp-PLA2 activity level in nmol/min/mL from which the sample Lp-PLA2 activity is derived.
The PLAC® Test for Lp-PLA2 Activity also includes controls. Controls should be included in each run or in accordance with the user's laboratory's quality control policies.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PLAC® Test for Lp-PLA2 Activity:
The document primarily focuses on non-clinical performance testing to demonstrate substantial equivalence to a predicate device. There is limited information on clinical acceptance criteria against specific clinical endpoints derived from a prospective study. The "acceptance criteria" presented are primarily for analytical performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document provides analytical performance criteria rather than clinical effectiveness criteria. The "Acceptance Criteria" column below is extracted directly from the precision tables or implied by the statements for other analytical metrics.
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision (Total CV) | ≤8% | Lot 1: Kit Control Low (2.6%), Kit Control High (2.2%), Sample 1 (2.0%), Sample 2 (2.0%), Sample 3 (2.4%), Sample 4 (1.5%) |
| Lot 2: Kit Control Low (2.3%), Kit Control High (2.3%), Sample 1 (2.1%), Sample 2 (2.7%), Sample 3 (2.9%), Sample 4 (2.1%) | ||
| Lot 3 (partial data): Kit Control High (2.3%), Sample 1 (2.2%), Sample 2 (2.2%), Sample 3 (2.4%), Sample 4 (2.1%) | ||
| *All reported total CVs are |
§ 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).