HYDRAGEL CSF ISOFOCUSING KITS by MORAX

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.

Device Description

Not Found

AI/ML Overview

This 510(k) summary does not contain the detailed study information regarding acceptance criteria and performance as it is a premarket notification for substantial equivalence, not a clinical study report. The document states that the device is substantially equivalent to legally marketed predicate devices without providing explicit acceptance criteria or a dedicated study demonstrating performance against specific metrics as would be found in a clinical trial report.

However, based on the provided text, we can infer some general information about the device's intended use and the nature of its performance.

Inferences from the document:

Device Function: The HYDRAGEL 3 CSF ISOFOCUSING and HYDRAGEL 9 CSF ISOFOCUSING kits are designed for the qualitative detection of oligoclonal bands in cerebrospinal fluid (CSF) and confirmation of their immunoglobulin character for aiding in the diagnosis of certain CNS diseases like multiple sclerosis.
Performance Claim: The use of enzyme-labeled antibodies increases sensitivity, allowing analysis on unconcentrated CSF.
Substantial Equivalence: The FDA's review determined substantial equivalence to predicate devices marketed prior to May 28, 1976. This implies that the device's performance is considered comparable to existing, legally marketed devices.

Missing Information (not found in the provided document):

The document does not provide the following information:

A table of acceptance criteria and reported device performance.
Sample size used for the test set or data provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for the test set.
Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
Information on a standalone (algorithm only) performance study.
The type of ground truth used (e.g., pathology, outcomes data).
The sample size for the training set.
How the ground truth for the training set was established.

Conclusion:

This document is a regulatory approval letter based on a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device. It typically does not include the detailed performance study results, acceptance criteria, ground truth establishment, or expert involvement that would be found in a comprehensive clinical study report. The FDA concluded that the device is substantially equivalent to existing devices based on the information provided in Sebia's 510(k) submission (K033277).

Summary

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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.

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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

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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 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)

Regulation Number and Section

§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.

(a)
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.(b)
Classification. Class II (performance standards).