(88 days)
This HDL-Cholesterol procedure is intended for Invitro Diagnostic use in the automated, quantitative determination of high-density lipoprotein-cholesterol (HDL) in serum. Lipoproteins measurements are use in the diagnosis and treatment of lipid disorders(such as diabetes melitus), artherosclerosis and various liver and renal diseases.
Not Found
This document is a 510(k) clearance letter from the FDA for a device named "HDL-CHOLESTEROL." It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance, or details of a study that proves the device meets specific criteria.
Therefore, I cannot provide the requested information from this document. The letter focuses on regulatory approval based on substantial equivalence, not on the results of a performance study with detailed acceptance criteria.
§ 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.