← Product Code [CFF](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF) · K033277 # HYDRAGEL CSF ISOFOCUSING KITS (K033277) _Morax · CFF · Nov 4, 2003 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K033277 ## Device Facts - **Applicant:** Morax - **Product Code:** [CFF](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF.md) - **Decision Date:** Nov 4, 2003 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 866.5510 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Intended 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-IgG 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. ## Device Story The HYDRAGEL 3/9 CSF ISOFOCUSING kits are in vitro diagnostic assays for qualitative detection of oligoclonal bands in CSF. The device utilizes high-resolution isoelectric focusing (IEF) to separate CSF and serum proteins, followed by immunofixation using anti-IgG antisera to confirm the immunoglobulin character of the bands. Enzyme-labeled antibodies are employed to enhance sensitivity, allowing analysis of unconcentrated CSF. The procedure is performed in a clinical laboratory setting by trained laboratory personnel. Results are obtained via visual, comparative interpretation of the electrophoretic patterns of paired CSF and serum samples. The presence of oligoclonal bands in CSF, not present in the corresponding serum, indicates intrathecal synthesis of immunoglobulins, aiding clinicians in the diagnosis of CNS inflammatory processes like multiple sclerosis. ## Clinical Evidence No clinical data provided. The submission relies on bench testing and performance characteristics inherent to the established isoelectric focusing and immunofixation methodology for CSF protein analysis. ## Technological Characteristics In vitro diagnostic kit utilizing high-resolution isoelectric focusing (IEF) on agarose gels. Employs immunofixation with anti-IgG antisera and enzyme-labeled antibodies for detection. The system is manual/semi-automated for laboratory use. No electronic components, software, or connectivity features. Sterilization not applicable to the chemical/reagent-based assay components. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all capital letters. The text is in a bold, sans-serif font and is centered horizontally. The words are arranged on a single line, with the word "DEPARTMENT" appearing first, followed by "OF HEALTH & HUMAN SERVICES". Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Sebia, Inc. c/o Borek Janik, Ph.D. Morax-Official Correspondent 13805 Waterloo Chelsea, Michigan 48118 NOV - 4 2003 Re: k033277 Trade/Device Name: HYDRAGEL 3 CSF ISOFOCUSING PN 4353 HYDRAGEL 9 CSF ISOFOCUSING PN 4355 Regulation Number: 21 CFR § 866.5510 Regulation Name: Immunoglobulins A, G, M, D, E Immunological Test System Regulatory Class: II Product Code: CFF Dated: October 4, 2003 Received: October 10, 2003 Dear Dr. Janik: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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. {1}------------------------------------------------ Page 2 - If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Steven Sutman Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Page 1 of 1 510(k) Number (if known): K033277 (Special 510(k): Device Modification) | Device name: | HYDRAGEL 3 CSF ISOFOCUSING | PN 4353 | |--------------|----------------------------|---------| | Device name: | HYDRAGEL 9 CSF ISOFOCUSING | PN 4355 | ## 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-IgG 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. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office, of Device Evaluatio leves Jor Division Sim : Off Office of in Vita Diagnostic Device Evaluation and Salety **Prescription Use** (Per 21 CFR 801.109) / 500 k) - - Over-The Counter Use ______________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K033277](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K033277) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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