(34 days)
Reagent:
HDL reagent, when used in conjunction with SYNCHRON LX® System(s) and SYNCHRON® Systems Lipid Plus Calibrator, is intended for the quantitative determination of HDL Cholesterol (HDL) in the high density lipoprotein (HDL) fraction of human serum or plasma.
HDL reagent, when used in conjunction with SYNCHRON CX® CE/DELTA/PRO System(s) and SYNCHRON® Systems Lipid Plus Calibrator, is intended for the quantitative determination of HDL Cholesterol (HDL) in the high density lipoprotein (HDL) fraction of human serum or plasma.
Calibrator:
The SYNCHRON® Systems Lipid Plus Calibrator 1& 2, in conjunction with specified assays on the SYNCHRON® Systems, are intended to provide points of reference in the measurement of selected human lipids and proteins.
Reagent:
The SYNCHRON LX® and CX® CE/DELTA/PRO System(s) HDL reagent is designed for optimal performance on the SYNCHRON LX® and CX® CE/DELTA/PRO System(s). The reagent kit contains two 200-test cartridges that are packaged separately from the associated calibrators.
Calibrator:
The SYNCHRON® Systems Lipid Plus Calibrator set is a two level readyto-use human serum-based liquid calibrator set manufactured by Beckman Coulter, Inc. Each kit contains 1 X 3 mL bottles of each level of calibrator (identified as Level 1 and Level 2).
This document describes the SYNCHRON® Systems HDL Cholesterol (HDL) Reagent and SYNCHRON® Systems Lipid Plus Calibrators 1 & 2.
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1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as pass/fail thresholds in the typical sense for a diagnostic device algorithm. Instead, it presents performance data to demonstrate substantial equivalence to a predicate device. The performance is assessed through method comparison and imprecision studies.
Since the device is a reagent and calibrator for laboratory analysis, the "acceptance criteria" are implicitly met when the performance data shows comparable results to the predicate device and within expected analytical ranges for such tests. For this type of device, the correlation (r-value) in method comparison and precision (CV%) are key indicators of performance.
Implicit Acceptance Criteria and Reported Performance for SYNCHRON® Systems HDL Reagent:
| Performance Metric | Acceptance Criteria (Implicit, based on typical clinical chemistry standards for substantial equivalence) | Reported Device Performance (SYNCHRON HDL) |
|---|---|---|
| Method Comparison (vs. Predicate SYNCHRON HDLD) | Slope close to 1.0, Intercept close to 0, and a high correlation coefficient (r > 0.95 or 0.975 typically) | SYNCHRON CX: Slope = 0.992, Intercept = -2.8, r = 0.994 (n=79) |
| SYNCHRON LX: Slope = 1.000, Intercept = -2.8, r = 0.993 (n=79) | ||
| Within-Run Imprecision (%CV) | Usually |
§ 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.