HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA

K012291 · The Binding Site, Ltd. · CFN · Aug 20, 2001 · Immunology

Device Facts

• Record ID: K012291
• Device Name: HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA
• Applicant: The Binding Site, Ltd.
• Product Code: CFN · Immunology
• Decision Date: Aug 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

This kit is intended for quantifying IgG subclasses 1, 2, 3 and 4 immunoglobulins in serum on the BNI. Measurement of these immunoglobulins aids in the diagnosis of immune deficiency and the body's lack of ability to resist infectious agents.

Device Story

The Human IgG Subclass Liquid Reagent Kits are in vitro diagnostic reagents designed for use on the Behring BNII Analyser. The system measures IgG subclass concentrations (1, 2, 3, and 4) in patient serum samples. The device utilizes immunochemical principles to quantify these immunoglobulins. The output is a quantitative measurement of IgG subclasses, which clinicians use to assess immune function and diagnose immune deficiency disorders. The device is intended for use in clinical laboratory settings by trained laboratory personnel. The resulting data assists healthcare providers in evaluating a patient's ability to resist infectious agents.

Technological Characteristics

Liquid reagent kit for immunochemical quantification of IgG subclasses. Designed for use on the Behring BNII Analyser. Operates via immunochemical assay principles.

Indications for Use

Indicated for the quantification of IgG subclasses 1, 2, 3, and 4 in human serum to aid in the diagnosis of immune deficiency and impaired resistance to infectious agents.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol.

AUG 2 0 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

The Binding Site, Limited c/o Mr. Jay H. Geller West Tower, Suite 4000 2425 West Olympic Boulevard Santa Monica, California 90404

Re: K012291

> Trade Name: Human IgG Subclass Liquid Reagent Kits (for use on the Behring BNII Analyser)

Regulation Number: 21 CFR & 866.5510 Regulatory Class: II Product Code: CFN Dated: July 19, 2001 Received: July 20, 2001

Dear Mr. Geller:

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.

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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 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Autman

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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## INDICATIONS FOR USE STATEMENT

Human IgG Subclass Liquid Reagent Kits (for use on Device Name: the Behring BNII Analyser) (Product Code LK001.TA)

Indications for Use: This kit is intended for quantifying IgG subclasses 1, 2, 3 and 4 immunoglobulins in serum on the BNI. Subcrasses if 2, 3 and innoglobulins aids in the diagnosis of Measurement of chebe immandy ond the body's lack of ability to resist infectious agents.

Ouchini Bautista
(Division Sign-Off)

510(k) Number.

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