K-ASSAY IGG

K993281 · Kamiya Biomedical Co. · DEW · Nov 9, 1999 · Immunology

Device Facts

• Record ID: K993281
• Device Name: K-ASSAY IGG
• Applicant: Kamiya Biomedical Co.
• Product Code: DEW · Immunology
• Decision Date: Nov 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

The K-ASSAY IgG Assay is intended to be used for the quantitative determination of IgG in human serum by immunoturbidimetric assay. Measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. FOR IN VITRO DIAGNOSTIC USE.

Device Story

K-ASSAY IgG is an in vitro diagnostic reagent for quantitative measurement of IgG in human serum. Operates via immunoturbidimetric assay principle; utilizes antigen-antibody reaction to produce turbidity proportional to IgG concentration. Used in clinical laboratory settings by trained laboratory personnel. Output is a quantitative IgG value; assists clinicians in diagnosing protein metabolism disorders and immune system function. Benefits patients by providing diagnostic data for managing infectious disease susceptibility and metabolic health.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Immunoturbidimetric assay for quantitative IgG measurement in human serum. In vitro diagnostic reagent format. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for quantitative determination of IgG in human serum to aid in diagnosis of abnormal protein metabolism and immune deficiency/inability to resist infectious agents. For in vitro diagnostic use.

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

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## NOV - 9 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Colin Getty Vice President. Clinical Diagnostics Kamiya Biomedical Company 910 Industry Drive Seattle, Washington 98188

Re: K993281 Trade Name: K-ASSAY IgG Regulatory Class: II Product Code: DEW Dated: September 27, 1999 Received: September 30, 1999

### Dear Mr. Getty:

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

Sincerely yours,

Steven Sutman

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

510(k) Number (if known): K193281

Device Name: K-ASSAY IgG.

#### Indications for Use:

The K-ASSAY IgG Assay is intended to be used for the quantitative determination of IgG in human serum by immunoturbidimetric assay. Measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. FOR IN VITRO DIAGNOSTIC USE.

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Concurrence of CDRH, Office of Device Evaluation (ODE) 1993281

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Optional Format 1-2-96)