# K974854: Hydragel-Mini Lipo Kit-PN 4093, Hydragel Lipo Kit-PN 4007, Hydragel Lipo Maxi Kit-PN 4207

- Pathway: 510(k) (Traditional)
- Applicant: Morax
- Decided: Oct 7, 1998 after 282 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. The FDA summary names no predicate by number.

## Indications for use
The HYDRAGEL-MINI LIPO, HYDRAGEL LIPO, HYDRAGEL LIPO MAXI, HYDRAGEL 7 LIPO, and HYDRAGEL 15/30 LIPO kits are designed for determination of lipoprotein profiles in human serum. All HYDRAGEL LIPO kits utilize the same composition of alkaline buffered HYDRAGEL LIPO agarose gels, same reagents and the same procedure. The only differences among the individual kits are the number of samples per gel and that some kits are for the manual and some for the automated format: The HYDRAGEL-MINI LIPO, HYDRAGEL LIPO and HYDRAGEL LIPO MAXI kits are designed for use with a manual electrophoresis apparatus. These Kits are intended to run up to 5, 8 and 10 samples per gel, respectively. The HYDRAGEL 7 LIPO and HYDRAGEL 15/30 LIPO 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. The resulting electrophoregrams 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. Indication of the qualitative (presence of abnormal or absence of normal fractions) or semi-quantitative (relative increase or decrease of fractions) abnormalities necessitates further lipoprotein analyses.

Source page: https://510kreport.com/device/K974854
Methodology: https://510kreport.com/methodology