# K022053: Hydragel 7 Lipoprotein (E), PN 4114 & Hydragel Lipoprotein (E) 15/30 PN 4134

- Pathway: 510(k) (Special)
- Applicant: Sebia
- Decided: Jul 12, 2002 after 18 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
The HYDRAGEL 7 LIPOPROTEIN(E) and HYDRAGEL LIPOPROTEIN(E) 15/30 kits are designed for determination of lipoprotein profiles in human serum. They all utilize the same composition of alkaline buffered agarose gels, same reagents and the same procedure. They are all designed for use with the semi-automated HYDRASYS electrophoresis apparatus. The only differences among the individual kits are the intended number of samples per gel: 7, 15 or 30 samples. The assay is carried out in two stages: electrophoresis on agarose gel to separate the VLDL, LDL and HDL as well as chylomicrons when present, visualization of lipoprotein fractions with a lipid specific Sudan black stain; the excess of stain is removed with an alcoholic solution. The resulting erectrophoregrams can be evaluated visually for pattern abnormalities or by densitometry to obtain approximate, relative quantification of individual zones. Fredrickson classification of lipoproteins aids in the interpretation of lipoprotein patterns. Both the qualitative (presence of abnormal or absence of normal fractions) and semiquantitative (relative increase or decrease of fractions) abnormalities necessitate further lipoprotein analyses. The procedure is indicated for the general population for determination of lipoprotein profiles.

Source page: https://510kreport.com/device/K022053
Methodology: https://510kreport.com/methodology