BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG

K992790 · Brahms Diagnostica, LLC · JZO · Nov 12, 1999 · Immunology

Device Facts

• Record ID: K992790
• Device Name: BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG
• Applicant: Brahms Diagnostica, LLC
• Product Code: JZO · Immunology
• Decision Date: Nov 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5870
• Device Class: Class 2

Indications for Use

DYNOtest anti-Tgn is a competitive radioimmunoassay (RIA) for the quantitative determination of autoantibodies against thyroglobulin (Tg) in human serum using the coated tube technique. The DYNOtest anti-Tg, kit is used as an aid in the diagnosis of Hashimoto's thyroiditis and Graves' disease, autoimmune diseases affecting the thyroid gland.

Device Story

Competitive radioimmunoassay (RIA) for quantitative measurement of anti-thyroglobulin antibodies in human serum. Input: patient serum sample; Principle: competitive binding between sample anti-thyroglobulin antibodies and 125I-labeled thyroglobulin for binding sites on a coated tube; Output: radioactivity count inversely proportional to antibody concentration. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing autoimmune thyroid conditions (Hashimoto's, Graves').

Clinical Evidence

Clinical correlation study using 74 serum samples from patients with Graves' disease, Hashimoto's thyroiditis, and non-autoimmune thyroid disease. Comparison against Orgentec Anti-Tg ELISA yielded 70.3% overall agreement (52/74 samples).

Technological Characteristics

Competitive radioimmunoassay (RIA) using coated tube technique. Employs 125I-labeled thyroglobulin as tracer. Measures radioactivity inversely proportional to antibody concentration. In vitro diagnostic kit.

Indications for Use

Indicated for the quantitative determination of anti-thyroglobulin autoantibodies in human serum as an aid in the diagnosis of Hashimoto's thyroiditis and Graves' disease.

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.

Predicate Devices

• Orgentec Anti-Tg ELISA (K952130)

Submission Summary (Full Text)

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NOV 1 2 1999

I.

# SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness is being submitted in accordance with the requirements of The Safe Medical Devices Act of 1990 (SMDA 1990) and 21 CFR 807.92.

| GENERAL INFORMATION<br>Date of Summary Preparation: | October 15, 1999 |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Distributor: | BRAHMS Diagnostica, LLC<br>29 South Peachtree Street<br>Norcross, Georgia 30092 |
| Manufacturer: | BRAHMS Diagnostica, GmbH<br>Komturstrasse 19-20<br>12099 Berlin, Germany |
| Contact Person: | H. Lee Herron<br>Partner<br>BRAHMS Diagnostica, LLC<br>29 South Peachtree Street<br>Norcross, Georgia 30092<br>Tel: [phone]<br>Fax: [phone] |
| Device Name: | DYNOtest® anti-Tgₙ |
| Common or Usual Name: | Radioimmunoassay kit for the determination of<br>anti-thyroglobulin antibodies |
| Classification:<br>Name:<br>Class<br>CFR: | Thyroid autoantibody immunological test system<br>Class II<br>21 CFR 866.5870 |
| Substantial Equivalence To: | Orgentec Anti-Tg ELISA |

#### II. INTENDED USE

DYNOtest anti-Tgn is a competitive radioimmunoassay (RIA) for the quantitative determination of autoantibodies against thyroglobulin (Tg) in human serum using the coated tube technique. The DYNOtest anti-Tg, kit is used as an aid in the diagnosis of Hashimoto's thyroiditis and Graves' disease, autoimmune diseases affecting the thyroid gland.

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### III. DEVICE DESCRIPTION

DYNOtest anti-Tg, is a competitive radioimmunoassay intended for the quantitative determination of autoantibodies against thyroglobulin in human sera using a coated tube technique. Human polyclonal antibodies against thyroglobulin bound to the solid phase compete with autoimmune antithyroglobulin antibodies in the sample for 1351 labeled thyroglobulin. Following incubation, unreacted labeled thyroglobulin is washed from the tube and radioactivity bound to the tube is counted. The measured radioactivity is inversely proportional to the quantity of anti-thyroglobulin antibody in the sample.

#### IV. COMPARISON TO PREDICATE DEVICE

The DYNOtest® anti-Tgn immunoassay kit is similar to the Orgentec Anti-Tg ELISA (K952130) in the indications for use, performance characteristics and results. The DYNOtest anti-Tg, test differs from the Orgentec Anti-Tg ELISA in assay format, solid phase and signal. In the DYNOtest anti-Tgn assay, human polyclonal antibodies against thyroglobulin on the coated tube solid phase compete for radioactively labeled thyroglobulin with antithyroglobulin antibodies in the sample. The Orgentec Anti-Tg assay uses purified human thyroglobulin adhered to the microplate solid phase to capture antithyroglubulin antibodies. Detection of the antithyroglobulin antibodies is accomplished by incubation with horseradish peroxidase anti-human IgG antibody followed by incubation with enzyme substrate and determination of optical density at 450 nm.

Substantial equivalence to the Orgentec Anti-Tg ELISA kit cleared under K952130 is based on clinical comparison using 74 serum samples from patients with Graves' disease, Hashimoto's thyroiditis and non-autoimmune thyroid disease. Overall agreement based on a 2 X 2 agreement table was 52/74 = 70.3%.

| | | Orgentec Anti-Tg ELISA | |
|---------------------|----------|------------------------|----------|
| DYNOtest<br>Anti-Tg | | Positive | Negative |
| | Positive | 27 | 9 |
| | Negative | 13 | 25 |
| | | % Agreement = 70.2% | |

% Agreement = 70.3%

This correlation study demonstrates that the DYNOtest anti-Tgn assay is substantially equivalent to the legally marketed predicate device, Orgentec Anti-Tg ELISA assay.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

NOV 1 2 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. H. Lee Herron Partner, BRAHMS, LLC BRAHMS Diagnostica, LLC 29 South Peachtree Street Norcross, Georgia 30092

Re: K992790 Trade Name: DYNOtest® anti-Tgg Regulatory Class: II Product Code: JZO Dated: August 18, 1999 Received: August 19, 1999

Dear Mr. Herron:

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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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/cdrl/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): K992790 Device Name: DYNOtest anti-Tgn

Indications For Use:

DYNOtest anti-Tg, is a competitive radioimmunoassay (RIA) for the quantitative determination of autoantibodies against thyroglobulin (Tg) in human serum using the coated tube technique. The DYNOtest anti-Tg, kit is used as an aid in the diagnosis of Hashimoto's thyroiditis and Graves' disease, autoimmune diseases affecting the thyroid gland.

#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K992790 |

Prescription Use V (Per 21 CFR 801.109)

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OR

Over-The-Counter Use