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The HYDRAGEL 6 CSF kit is designed for the qualitative detection of "oligocional" 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", Ig character of oligoclonal banding. Visual, comparative interpretation of immunofixation patterns of immunodobulins in high resolution separations of CSF and serum proteins from the same patient allows 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-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.

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This document is a 510(k) clearance letter for the HYDRAGEL 6 CSF Kit and does not contain the detailed study information regarding acceptance criteria and performance of the device. The letter simply states that the FDA has determined the device to be "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market.

Therefore, I cannot provide the requested information based on the provided text. To answer your questions, I would need to review the original 510(k) submission document or a separate clinical study report from the manufacturer.

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