(65 days)
The Olympus HDL Cholesterol Test System contains HDL Cholesterol Reagent, HDL Cholesterol Calibrator, and Assayed HDL/LDL Cholesterol Control materials intended for use on the Olympus Family of Clinical Chemistry Analyzers for the quantitative determination of HDL Cholesterol concentrations in human serum and plasma.
The Olympus HDL Cholesterol Calibrator is a lyophilized human serum intended to provide an HDL concentration of known value for use in calibration of the Olympus HDL Cholesterol Reagent used on the Olympus family of Clinical Chemistry Analyzers.
The Olympus HDL/LDL Cholesterol Control consists of lyophilized human sera. These assayed control sera are designed to monitor the recovery and precision of the Olympus HDL Cholesterol Reagent used on the Olympus family of Clinical Chemistry Analyzers.
HDL Cholesterol demonstrates a strong and independent association with the risk of coronary artery disease and is used in the initial screening for hypercholesterolemia.
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This document is a 510(k) premarket notification from the FDA, confirming that the Olympus HDL Cholesterol Test System is substantially equivalent to legally marketed predicate devices. It does not contain the detailed acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or validation studies.
The provided text focuses on the regulatory approval process rather than specific performance metrics or detailed study results. Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement from this document.
The document states:
- Device Name: Olympus HDL Cholesterol Test System (comprising HDL Cholesterol Reagent, HDL Cholesterol Calibrator, and HDL/LDL Cholesterol Control)
- Intended Use: Quantitative determination of HDL Cholesterol concentrations in human serum and plasma on Olympus Family of Clinical Chemistry Analyzers.
- Indication for Use: "HDL Cholesterol demonstrates a strong and independent association with the risk of coronary artery disease and is used in the initial screening for hypercholesterolemia."
To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSED), a clinical study report, or a validation study submitted as part of the 510(k) application.
§ 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.