(47 days)
The SYNCHRON Systems Cholesterol (CHOL) Reagent, when used in conjunction with SYNCHRON Systems Multi Calibrator, is intended for the quantitative determination of human cholesterol in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.
The SYNCHRON Systems Cholesterol (CHOL) Reagent in conjunction with SYNCHRON Systems Multi Calibrator, is intended for use on Beckman's SYNCHRON Systems Clinical Systems.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the SYNCHRON® Systems Cholesterol (CHOL) Reagent:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a separate section with specific numerical thresholds for performance. Instead, it presents performance data (method comparison and imprecision) which is presumably used to demonstrate substantial equivalence to the predicate device. The implied acceptance criteria are that the new device's performance should be comparable to or better than the predicate's and generally accepted clinical standards for cholesterol measurement.
| Performance Metric | Implied Acceptance Criteria (Based on general clinical standards for cholesterol) | Reported Device Performance |
|---|---|---|
| Method Comparison (vs. Predicate) | Close to 1.0 (slope), close to 0 (intercept), high correlation (r > 0.99) | Slope: 0.983 |
| Intercept: 2.41 mg/dL | ||
| r (correlation coefficient): 0.9996 | ||
| (Compared to SYNCHRON Systems Cholesterol (CHOL) Reagent predicate) | ||
| Method Comparison (vs. Reference Method) | Close to 1.0 (slope), close to 0 (intercept), high correlation (r > 0.99) | Slope: 1.002 |
| Intercept: -2.07 mg/dL | ||
| r (correlation coefficient): 0.9961 | ||
| (Compared to Abell-Kendall Reference Method) | ||
| Within-Run Imprecision (Default Range) | Typical CVs for cholesterol assays are generally |
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(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.