HYDRAGEL 6 CSF KIT

K981048 · Morax · CFF · Oct 7, 1998 · Immunology

Device Facts

• Record ID: K981048
• Device Name: HYDRAGEL 6 CSF KIT
• Applicant: Morax
• Product Code: CFF · Immunology
• Decision Date: Oct 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

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.

Device Story

In vitro diagnostic kit for qualitative detection of oligoclonal bands in cerebrospinal fluid (CSF). Uses immunofixation electrophoresis to compare CSF and serum protein patterns from same patient. Employs enzyme-labeled antibodies to increase sensitivity, allowing analysis of unconcentrated CSF. Performed in clinical laboratory settings by trained technicians. Results interpreted visually by clinicians to identify intrathecal immunoglobulin synthesis, supporting diagnosis of CNS inflammatory conditions like multiple sclerosis.

Technological Characteristics

Immunofixation electrophoresis kit; utilizes enzyme-labeled antibodies for detection; high-resolution separation of CSF and serum proteins; supports analysis of unconcentrated CSF samples.

Indications for Use

Indicated for patients suspected of having central nervous system (CNS) diseases, such as multiple sclerosis, where detection of oligoclonal banding and intrathecal immunoglobulin synthesis aids diagnosis.

Regulatory Classification

Identification

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Submission Summary (Full Text)

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OCT 7 1998

MORAX c/o Borek Janik, Ph.D. 13805 Waterloo Road Chelsea, Michigan 48118

Re: K981048/S1 Trade Name: HYDRAGEL 6 CSF Kit Requlatory Class: II Product Code: CFFF Dated: August 21, 1998 Received: August 25, 1998

Dear Dr. Janik:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known): K981048

Device name:

HYDRAGEL 6 CSF Kit

## Indications For Use:

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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (OI

te E. Martin

(Division Sign-Off)
Division of Clinical Laboratory Devices K981048
510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The Counter-Use . . . .

(Optional Format 1-2-96)