(59 days)
Intended for the In Vitro, quantitative determination of HDL Cholesterol in human serum on automated chemistry analyzers.
HDL Cholesterol measurements are used in the diagnosis and treatment of disorders involving low HDL Cholesterol, which is associated with an increased risk of coronary heart disease and coronary artery disease.
Not Found
The provided text is a 510(k) clearance letter from the FDA for an "HDL Cholesterol (Automated) REAGENT." This document primarily covers the regulatory approval of the device and does not contain the specific technical details about acceptance criteria or the study used to prove the device meets them.
Therefore, I cannot provide the requested information based on the given input. The document is a regulatory approval letter, not a scientific study report or a detailed submission outlining performance characteristics.
To answer your questions, I would need to analyze a different type of document, such as:
- A summary of safety and effectiveness from the 510(k) submission.
- The applicant's performance study report.
- The labeling/instructions for use for the device, which often contains performance characteristics.
§ 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.