SPIFE URINE IFE

K982639 · Helena Laboratories · DAO · Nov 4, 1998 · Immunology

Device Facts

• Record ID: K982639
• Device Name: SPIFE URINE IFE
• Applicant: Helena Laboratories
• Product Code: DAO · Immunology
• Decision Date: Nov 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5550
• Device Class: Class 2

Intended Use

This kit is intended for the qualitative identification of monoclonal gammopathies in urine using protein electrophoresis and immunofixation. This kit could be a useful aid, in conjunction with other medical diagnostic tests, 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

SPIFE Urine IFE Kit performs qualitative identification of monoclonal gammopathies in urine samples. Process utilizes protein electrophoresis and immunofixation techniques. Used in clinical laboratory settings by trained personnel. Output consists of electrophoretic patterns interpreted by clinicians to identify abnormal protein bands. Results serve as diagnostic aid for conditions like multiple myeloma, collagen disorders, and chronic infections.

Clinical Evidence

No clinical data provided; device relies on established protein electrophoresis and immunofixation principles.

Technological Characteristics

In vitro diagnostic kit for urine protein electrophoresis and immunofixation. Utilizes standard electrophoretic separation and immunological precipitation principles. Manual or semi-automated laboratory procedure.

Indications for Use

Indicated for qualitative identification of monoclonal gammopathies in urine to aid in diagnosis of disease states such as multiple myeloma, collagen disorders, and chronic infections.

Regulatory Classification

Identification

An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.

Submission Summary (Full Text)

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NOV 4 1998 Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Pat Franks Assistant Director, Regulatory Affairs Helena Laboratories 1530 Lindbergh Drive Beaumont, Texas 77704

к982639/51 Re : Trade Name: SPIFE – Urine Immunofixation Electrophoresis Kit Requlatory Class: II Product Code: DAO Dated: October 20, 1998 Received: October 22, 1998

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 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 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will xerify 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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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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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): K982639

SPIFE Urine IFE Kit Device Name:

Indications for Use:

This kit is intended for the qualitative identification of monoclonal gammopathies in urine using protein electrophoresis and immunofixation.

This kit could be a useful aid, in conjunction with other medical diagnostic tests, 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.

Peter E. Makin
(Division Sign-Off)

(Division Sign-Division of Clinical 510(k) Numbe

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

A. L.

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)