ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM

K991179 · Zeus Scientific, Inc. · DDC · Jun 17, 1999 · Immunology

Device Facts

• Record ID: K991179
• Device Name: ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
• Applicant: Zeus Scientific, Inc.
• Product Code: DDC · Immunology
• Decision Date: Jun 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5870
• Device Class: Class 2

Intended Use

The Zeus Scientific, Inc. Thyroglobulin IgG ELISA Test System is an enzyme linked immunosorbent assay (ELISA) for the qualitative and semi-quantitative detection of IgG autoantibodies to human thyroglobulin in human serum. The results of this serological test together with other clinical findings may aid in the diagnosis of thyroid diseases. This test is for in vitro diagnostic use.

Device Story

The Zeus Scientific, Inc. Thyroglobulin IgG ELISA Test System is an enzyme-linked immunosorbent assay (ELISA) used to detect IgG autoantibodies to human thyroglobulin in human serum samples. The device functions as an in vitro diagnostic tool in clinical laboratory settings. It provides qualitative and semi-quantitative results that clinicians use in conjunction with other clinical findings to assist in the diagnosis of thyroid diseases. The test is intended for prescription use.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) for detection of IgG autoantibodies. In vitro diagnostic test system.

Indications for Use

Indicated for the qualitative and semi-quantitative detection of IgG autoantibodies to human thyroglobulin in human serum to aid in the diagnosis of thyroid diseases. For in vitro diagnostic use.

Regulatory Classification

Identification

A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.

Submission Summary (Full Text)

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JUN 17 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Mark J. Kopnitsky Vice President. Research and Development Zeus Scientific, Inc. 200 Evans Way Branchburg, New Jersey 08876

Re: K991179

Trade Name: Zeus Scientific, Inc., Thyroglobulin IgG ELISA Test System Regulatory Class: II Product Code: DDC Dated: April 5, 1999 Received: April 7, 1999

Dear Mr. Kopnitsky:

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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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 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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510(k) Number (if known):

Device Name: Zeus Scientific, Inc., Thyroglobulin IgG ELISA Test System

## Indications for Use:

The Zeus Scientific, Inc. Thyroglobulin IgG ELISA Test System is an enzyme linked immunosorbent assay (ELISA) for the qualitative and semi-quantitative detection of IgG autoantibodies to human thyroglobulin in human serum. The results of this serological test together with other clinical findings may aid in the diagnosis of thyroid diseases. This test is for in vitro diagnostic use.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Kittie E. Madim

K991179 510(k) Num

Prescription Use
(Per 21 CFR 801,109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)