# K990250: Hydragel LDL/HDL Chol Direct Kit-P.N. 4005, Hydragel 7 LDL/HDL Chol Direct Kit-P.N. 4103, Hydragel LDL/HDL Chol Direct 0

- Pathway: 510(k) (Traditional)
- Applicant: Morax
- Decided: Jun 18, 1999 after 143 days
- Product code: LBT (Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl)
- Device class: 1
- Regulation: 21 CFR 862.1475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
HYDRAGEL LDL/HDL CHOL DIRECT, HYDRAGEL 7 LDIYHDL 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 2 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.

Source page: https://510kreport.com/device/K990250
Methodology: https://510kreport.com/methodology