SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389

K024162 · Helena Laboratories · CFF · Feb 19, 2003 · Immunology

Device Facts

• Record ID: K024162
• Device Name: SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389
• Applicant: Helena Laboratories
• Product Code: CFF · Immunology
• Decision Date: Feb 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

The SPIFE 3000 TITAN GEL IgG IEF Kit is intended for the qualitative identification of IgG-specific oligoclonal banding in paired serum and CSF samples by agarose gel isoelectric focusing and immunoblotting, as an aid in the diagnosis of inflammatory disease of the central nervous system, such as caused by multiple sclerosis

Device Story

Device performs qualitative identification of IgG-specific oligoclonal banding; utilizes agarose gel isoelectric focusing and immunoblotting. Input: paired serum and CSF samples. Output: visual banding patterns on gel. Used in clinical laboratory settings by trained laboratory personnel. Results interpreted by clinicians to aid in diagnosis of CNS inflammatory diseases like multiple sclerosis.

Clinical Evidence

No clinical data provided in the document; substantial equivalence based on bench testing and technological comparison.

Technological Characteristics

Agarose gel isoelectric focusing and immunoblotting test system. Class II, Product Code CFF. Regulation 21 CFR 866.5510.

Indications for Use

Indicated for qualitative identification of IgG-specific oligoclonal banding in paired serum and CSF samples to aid in diagnosing central nervous system inflammatory diseases, such as multiple sclerosis.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## FEB 1 9 2003

Mr. Eric Petersen Vice President Helena Laboratories 1530 Lindbergh Drive Beaumont, TX 77704

Re: k024162

> Trade/Device Name: SPIFE 3000 Titan Gel IgG IEF Kit Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, and E immunological test system Regulatory Class: Class II Product Code: CFF Dated: February 5, 2003 Received: February 6, 2003

Dear Mr. Petersen:

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 (OS) regulation (21 CFR Part 820).

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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.

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 [phone]. 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 [phone] or [phone] 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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510(k) Number (if known):

Device Name: SPIFE 3000 Titan Gel IgG IEF Kit

Indications for Use:

The SPIFE 3000 TITAN GEL IgG IEF Kit is intended for the qualitative identification of IgG-specific oligoclonal banding in paired serum and CSF samples by agarose gel isoelectric focusing and immunoblotting, as an aid in the diagnosis of inflammatory disease of the central nervous system, such as caused by multiple sclerosis

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

J. Reeves for J. Bautista

Division of Clinical La

(Optional Format 1-2-96)

**510**(k)mber K024162