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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.

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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.

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HYDRAGEL CHOL-HDL, HYDRAGEL 7 CHOL-HDL, HYDRAGEL 15 CHOL-HDL and HYDRAGEL 30 CHOL-HDL kits are designed for quantification of the cholesterol carried by the HYDRAGEE 50 OFFE Friend or serum. This analysis is performed by electrophoresis on alkaline buffered (pH 9.4) agarose gels. The separated lipoproteins are visualized by a of alkaline banered (p). cholesterol-specific enzymatic reaction. The stained electrophoregrams are to be interpreted visually to confirm identification of the individual fractions and by densitometry to obtain viccurale, relative concentrations of cholesterol in the individual lipoprotein fractions if the somole's total cholesterol value is known, cholesterol distribution in g/l or mol/l concentrations can be calculated. Since the HDL cholesterol assay is of primary interest, laboratories may chose to measure the relative concentration of cholesterol only in the HDL fraction.

All HYDRAGEL CHOL-HDL kits utilize the same composition of alkaline buffered HYDRAGEL CHOL-HDL agarose gels and the same procedure. It is carried out 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 HYDRAGEL CHOL-HDL 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 CHOL-HDL, HYDRAGEL 15 CHOL-HDL and HYDRAGEL 30 CHOL-HDL 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.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria.

The document is a 510(k) clearance letter from the FDA for the HYDRAGEL CHOL-HDL Kits. It primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information for its marketing.

Specifically, the document lacks:

• A table of acceptance criteria or reported device performance.
• Details about sample size, data provenance, or ground truth establishment for any studies.
• Information on expert panels, adjudication methods, or MRMC studies.
• Mention of standalone algorithm performance.
• Any description of specific studies conducted to demonstrate clinical or analytical performance against predefined acceptance criteria.

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