POLYSLIT IFE KIT

K990998 · Helena Laboratories · CFF · Jun 28, 1999 · Immunology

Device Facts

• Record ID: K990998
• Device Name: POLYSLIT IFE KIT
• Applicant: Helena Laboratories
• Product Code: CFF · Immunology
• Decision Date: Jun 28, 1999
• 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 using agarose gel electrophoresis. This kit could be useful in the diagnosis of various disease states which typically exhibit abnormal patterns. Examples of such which typically include multiple myeloma, Waldenstrom's macroglobulinemia, hypergammaglobulinemia, collagen disorders and other chronic infections.

Device Story

Polyslit IFE Kit performs immunofixation electrophoresis (IFE) to separate immunoglobulins. Used in clinical laboratories by trained technicians; input consists of patient serum or other biological samples. Process involves agarose gel electrophoresis to resolve protein components; results visualized to identify abnormal immunoglobulin patterns. Output provides diagnostic information regarding protein abnormalities; assists clinicians in diagnosing conditions like multiple myeloma or chronic infections. Device functions as an in vitro diagnostic tool.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic kit for agarose gel electrophoresis. Utilizes standard electrophoretic separation principles for immunoglobulin analysis. Class I device, product code CFF.

Indications for Use

Indicated for the separation of immunoglobulins via agarose gel electrophoresis to assist in the diagnosis of disease states exhibiting abnormal protein patterns, including multiple myeloma, Waldenstrom's macroglobulinemia, hypergammaglobulinemia, 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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the edge. Inside the circle is a stylized graphic of three birds in flight, represented by curved lines. The seal is black and white and appears to be a logo or emblem.

## JUN 28 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Pat Franks Assistant Director, Regulatory Affairs 1530 Lindbergh Drive P.O. Box 752 Beaumont, Texas 77704-0752

Re: K990998 Trade Name: Polyslit IFE Kit Regulatory Class: I Product Code: CFF Dated: June 3, 1999 Received: June 9, 1999

## Dear Mr. 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 regulation (21 CFR Part 820) and that, through periodic QS 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.

{1}------------------------------------------------

## Page 2

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 [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

{2}------------------------------------------------

Page of

## 510(k) Number (if known): Jy99998

Device Name:

Indications for Use:

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

This kit could be useful in the diagnosis of various disease states which typically exhibit abnormal patterns. Examples of such which cypically Chilbre annual collagen disorders and other chronic infections.

Peter E. Mariani

(Division Sign-O 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)

11 Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)