(97 days)
This LDL-Cholesterol procedure is intended for Invitro Diagnostic use in the automated, quantitative determination of low-density lipoprotein-cholesterol (LDL) 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
The provided document is a 510(k) summary from the FDA for a device named "LDL-CHOLESTEROL." It is a regulatory clearance letter and does not contain information about the acceptance criteria, study details, or performance metrics of the device.
Therefore, I cannot provide the requested information based on the given input. The document confirms the device is substantially equivalent to legally marketed predicate devices, but it does not describe the specific studies or data that led to this determination.
§ 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.