# K960785: LFS Lipogel Assay Kit

- Pathway: 510(k) (Traditional)
- Applicant: Zaxis, Inc.
- Decided: Sep 3, 1996 after 190 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
Longest line of descent: 1 generation back to K833611 (1984). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K833611: Titan Gel Lipoprotein Electrophoresis, Helena Laboratories (1984) Summary page 3.
- K854057: Paragon Electrophoresis Sys Lipoprotein Reagent TE, Beckman Instruments, Inc. (1985) Summary page 3.

## Indications for use
The LFS Lipogel Assay Kit is indicated for the electrophoretic separation of lipoproteins in a gradient polyacrylamide gel. That is, the LFS Lipogel Assay Kit is an in vitro diagnostic device intended to test human plasma or serum for lipoproteins and their subfractions.

Source page: https://510kreport.com/device/K960785
Methodology: https://510kreport.com/methodology