(150 days)
HYDRAGEL LDLIHDL CHOL Direct K20, HYDRAGEL 7 LDLIHDL CHOL Direct and HYDRAGEL LDLHDL CHOL Direct 15/30 kits are designed for quantification of the cholesterol canied by the Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) fractions of human serum. The analysis is performed in two stages:
· electrophoresis on agarose get to separate the VLDL, LDL and HDL as well as chylomicrons,
· visualization of lipoprotein fractions based on a sensitive and cholesterol-specific enzymatic procedure involving the cholesterol esterase / cholesterol dehydrogenase system coupled with nitro blue tetrazolium chromogen.
The stained electrophoregrams are intended for visual interpretation to confirm identification of the individual fractions and for densitometry to obtain relative concentrations of cholesterol in the individual lipoprotein fractions. When the sample's total cholesterol value is known, cholesterol distribution in a/dL or mol/L concentrations can be calculated.
The test system is intended for the measurement of the LDL cholesterol and HDL cholesterol. The cholesterol values of only these two fractions are indicated as an aid in the diagnosis and treatment of lipid disorders.
The procedure is indicated for the general population for a direct measurement of:
- . the LDL cholestero! level regardless the triglyceride levels
- the HDL cholesterol level .
- the ratio LDL/HDL cholesterol .
The HYDRAGEL LDUHDL CHOL Direct K20 kit is designed for use with a manual electrophoresis apparatus, K20. The kit is intended to run up to 7 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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This document is a 510(k) premarket notification from the FDA, granting clearance for a medical device. It does not contain the detailed acceptance criteria and study information typically found in a clinical study report or a detailed validation document.
The document states that the FDA has reviewed the 510(k) and determined the device is "substantially equivalent" to legally marketed predicate devices. This means the manufacturer demonstrated that their device is as safe and effective as a device already on the market, but it does not typically involve the rigorous clinical study details you're asking for.
Therefore, I cannot provide the requested information from this document. The document refers to the device's "indications for use" and states that "The analysis is performed in two stages," but does not provide performance metrics, acceptance criteria, sample sizes, ground truth methodology, or expert qualifications.
The information you are requesting would usually be found in the 510(k) submission itself (which is not fully provided here) or in a separate validation report prepared by the manufacturer.
§ 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.