# K033277: Hydragel CSF Isofocusing Kits

- Pathway: 510(k) (Special)
- Applicant: Morax
- Decided: Nov 4, 2003 after 25 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. The FDA summary names no predicate by number.

## Indications for use
The HYDRAGEL 3 CSF ISOFOCUSING and HYDRAGEL 9 CSF ISOFOCUSING kits are 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-lgG antisera permits to prove or disprove the "true" IgG character of oligoclonal banding. Visual, comparative interpretation of immunofixation patterns of IgG in high resolution isoelectric separations of CSF and serum proteins from the same patient allows detection of oligoclonal banding that represents intrathecal synthesis of immunoglobulins. The HYDRAGEL 3 CSF ISOFOCUSING and HYDRAGEL 9 CSF ISOFOCUSING kits are 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. The use of enzyme labeled antibodies increases the sensitivity of detection so that the analysis can be generally performed on unconcentrated CSF. The only difference between the 3 CSF and 6 CSF kits is in the intended number of samples per gel: 3 and 9 CSF/serum sample pairs, respectively.

Source page: https://510kreport.com/device/K033277
Methodology: https://510kreport.com/methodology