HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER

K021081 · The Binding Site, Ltd. · DFZ · Jun 17, 2002 · Immunology

Device Facts

• Record ID: K021081
• Device Name: HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER
• Applicant: The Binding Site, Ltd.
• Product Code: DFZ · Immunology
• Decision Date: Jun 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

This kit is intended for the quantification of IgG subclasses in serum on the Hitachi 911 (7070). Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Device Story

The Human IgG Subclass Liquid Reagent Kit is an in vitro diagnostic assay designed for use on Hitachi 911/7070 turbidimetric analyzers. The device utilizes turbidimetric technology to measure IgG subclass concentrations in serum samples. It is intended for use by clinical laboratory professionals in a laboratory setting. The output, provided as quantitative concentration values, assists clinicians in diagnosing conditions related to abnormal protein metabolism and impaired immune response to infectious agents.

Clinical Evidence

No clinical data provided; device relies on analytical performance characteristics typical of turbidimetric reagent kits.

Technological Characteristics

Liquid reagent kit for turbidimetric analysis; designed for integration with Hitachi 911/7070 automated analyzers. Operates via immunoturbidimetric principle.

Indications for Use

Indicated for the quantification of IgG subclasses in human serum to aid in the diagnosis of abnormal protein metabolism and immune deficiency in patients.

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

## JUN 1 7 2002

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

Re: k021081

Device Name: Human IgG Subclass Liguid Reagent Kit for use on the Hitachi 911/7070 Turbidimetric Analyzer Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A. G. M. D. and E Immunological Test System Regulatory Class: II Product Code: DEZ Dated: May 28, 2002 Received: June 4, 2002

Dear Mr. Geller:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 1 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 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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## K021081 INDICATIONS FOR USE STATEMENT

Device Name: Human IgG Subclass Liquid Reagent Kit for use on the Hitachi 911/7070 Turbidimetric Analyser

Indications for Use: This kit is intended for the quantification of IgG subclasses in serum on the Hitachi 911 (7070). Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Sousan S. Altaie

(Division Sign-Off) Division of Clinical Labo 510(k) Number .

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Concurrence of CDHR, office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use_