# K012789: Modified to LDL/HDL Chol Direct Kit-P.N. 4005, 4103,4123

- Pathway: 510(k) (Special)
- Applicant: Morax
- Decided: Jan 17, 2002 after 150 days
- Product code: JHO (Electrophoretic Separation, Lipoproteins)
- 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 LDIL/HDL CHOL Direct K20, HYDRAGEL 7 LDL/HDL CHOL Direct and HYDRAGEL LDL/MHDL CHOL Direct 15/30 kits are designed for quantification of the cholesterol camied 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 gel to separate the VLDL, LDL and HDL as well as chylomicrons, visualization of lipoprotein fractions based on a sensifive and cholesterol-specific enzymatic procedure involving the cholesterol esterase / chalesterol dehydrogenase system coupled with nitro biue 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 g/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 generat 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 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.

Source page: https://510kreport.com/device/K012789
Methodology: https://510kreport.com/methodology