(66 days)
For the quantitative determination of HDL-Cholesterol in serum. For IN VITRO diagnostic use.
The procedure for HDL-Cholesterol precipitation in this formulation is based on the recommendations of Warnick, et.al. (2) and uses dextran sulfate and magnesium ions to precipitate the LDL and VLDL fractions.
This document is an FDA 510(k) clearance letter for an in vitro diagnostic device, specifically the "HDL Cholesterol Precipitating Reagent" (Catalog No. 205-51), and a subsequent "Indications For Use" statement.
Based on the provided text, there is no information available about acceptance criteria or a study that proves the device meets specific acceptance criteria.
The document states that the FDA has determined the device is "substantially equivalent" to predicate devices marketed before May 28, 1976. This substantial equivalence is a regulatory standard, not a direct performance acceptance criteria in the way a clinical study would establish it.
Therefore, I cannot provide the requested information in the table or address the subsequent points about sample size, experts, adjudication, MRMC studies, standalone performance, ground truth types, or training set details because the provided text does not contain this kind of performance data or study design information.
The "Indications for Use" section focuses on the purpose of the device (quantitative determination of HDL-Cholesterol in serum for IN VITRO diagnostic use) and the scientific basis for its precipitation method (using dextran sulfate and magnesium ions to precipitate LDL and VLDL based on recommendations by Warnick, et.al.). It does not detail specific performance metrics, clinical trials, or validation studies.
§ 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.