(143 days)
HYDRAGEL LDL/HDL CHOL DIRECT, HYDRAGEL 7 LDL/HDL CHOL DIRECT and HYDRAGEL LDL/HDL CHOL DIRECT 15/30 kits are designed for quantification of the cholesterol carried by the LDL and HDL lipoprotein fractions of human plasma or serum. The analysis is performed in two stages:
· electrophoresis on agarose gel to separate the VLDL, LDL and HDL as well as chylomicrons and Lp (a) when present,
· visualization of lipoprotein fractions based on a sensitive and cholesterol-specific enzymatic method involving cholesterol esterase and cholesterol oxidase, and a chromogenic system with reduced AEC (amino ethyl carbazole) and peroxidase.
The stained electrophoregrams are intended for visual interpretation to confirm identification of the individual fractions and for densitometry to obtain accurate, relative concentrations of cholesterol in the individual lipoprotein fractions If the sample's total cholesterol value is known, cholesterol distribution in g/dL or mol/L concentrations can be calculated. Since the LDL cholesterol and HDL cholesterol assays are of primary interest, laboratories may chose to measure the relative concentration of cholesterol only in the HDL and LDL fractions.
The procedure is indicated for the general population for a direct measurement of:
- the LDL cholesterol level regardless the triglyceride levels ◆
- . the HDL cholesterol level
- the ratio LDL/HDL cholesterol .
The HYDRAGEL LDL/HDL CHOL Direct kit is designed for use with a manual electrophoresis apparatus. The kit is intended to run up to 8 samples per gel.
The HYDRAGEL 7 LDL/HDL CHOL Direct and HYDRAGEL LDL/HDL CHOL Direct 15/30 kits are designed for use with the semi-automated Hydrasys electrophoresis apparatus. These kits are intended to run up to 7, 15 and 30 samples per gel, respectively.
Not Found
The document assesses the substantial equivalence of the HYDRAGEL LDL/HDL CHOL DIRECT devices to legally marketed predicate devices, focusing on their use for quantifying cholesterol carried by LDL and HDL lipoprotein fractions. While the document details the device's indications for use and the FDA's regulatory approval, it does not explicitly provide acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, ground truth types, or training set details as this information is not present in the provided text.
§ 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.