SPIFE IFE-6

K973040 · Helena Laboratories · CFF · Jan 2, 1998 · Immunology

Device Facts

• Record ID: K973040
• Device Name: SPIFE IFE-6
• Applicant: Helena Laboratories
• Product Code: CFF · Immunology
• Decision Date: Jan 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

This kit is intended for the separation of immunoglobulins in serum using agarose gel electrophoresis. This kit could be useful in the diagnosis of various disease states which typically exhibit abnormal patterns. Examples of such gammopathies are multiple myeloma, collagen disorders and other chronic infections.

Device Story

The SPIFE IFE-6 is an in vitro diagnostic kit designed for the separation of immunoglobulins in serum samples. It utilizes agarose gel electrophoresis to resolve protein components. The device is intended for use in clinical laboratory settings by trained laboratory personnel. By separating serum proteins, the device allows clinicians to identify abnormal patterns (gammopathies) associated with conditions like multiple myeloma, collagen disorders, and chronic infections. The output is a visual electrophoretic pattern on an agarose gel, which is interpreted by the healthcare provider to aid in clinical diagnosis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device utilizes agarose gel electrophoresis for the separation of serum immunoglobulins. It is an in vitro diagnostic kit designed for laboratory use.

Indications for Use

Indicated for the separation of immunoglobulins in serum via agarose gel electrophoresis to assist in the diagnosis of disease states exhibiting abnormal protein patterns, such as multiple myeloma, collagen disorders, and chronic infections.

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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IAN - 2 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Pat Franks Asst. Director Regulatory Affairs Helena Laboratories 1530 Lindbergh Drive P.O. Box 752 Beaumont, TX 77704-0752

Re: K973040 Trade Name: SPIFE IFE-6 Regulatory Class: I Product Code: CFF Dated: October 28, 1997 Received: October 30, 1997

Dear Ms. Franks:

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 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 vour 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 regulations 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 OS 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.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Butman

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):

Device Name: SPIFE IFE-6

Indications for Use:

This kit is intended for the separation of immunoglobulins in serum using agarose gel electrophoresis.

This kit could be useful in the diagnosis of various disease states which typically exhibit abnormal patterns. Examples of such gammopathies are multiple myeloma, collagen disorders and other chronic infections.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K973040

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)