# K981048: Hydragel 6 CSF Kit

- Pathway: 510(k) (Traditional)
- Applicant: Morax
- Decided: Oct 7, 1998 after 201 days
- Product code: CFF (Immunoelectrophoretic, Immunoglobulins, (G, A, M))
- Device class: 2
- Regulation: 21 CFR 866.5510
- 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 6 CSF kit is designed for the qualitative detection of "oligoclonal® bands in the electrophoretic patterns of cerebrospinal fluid (CSF). and confirmation of their immunoglobulin character. The use of anti-immunoglobulin antisera permits to prove or disprove the “true”, lg- character of oligoclonal banding. Visual, comparative interpretation of immunofixation patterns of immunoglobulins in high resolution separations of CSF and serum proteins from the same patient aliows detection of intrathecal synthesis of immunoglobulins. The HYDRAGEL 6 CSF kit is indicated when certain diseases of the central nervous system (CNS), such as multiple sclerosis, are suspected and the detection of oligoclonal banding and inflammatory processes (intrathecal synthesis of immunoglobulins) can aid to the diagnosis. Depending on the selection of detecting antisera (anti IgG, anti-igA and/or anti-igM) two to six CSF - serum sample pairs can be run on each gel. The use of enzyme labeled antibodies increases the sensitivity of detection so that the analysis can be generally performed on unconcentrated CSF.

Source page: https://510kreport.com/device/K981048
Methodology: https://510kreport.com/methodology