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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the DYNOtest® anti-Tgn device, focusing on acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define acceptance criteria as a standalone quantitative metric (e.g., "sensitivity must be >X%"). Instead, it focuses on demonstrating substantial equivalence to a predicate device. The performance is assessed through a direct comparison where the agreement between the new device and the predicate device is the key metric.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate device based on overall agreement.	Overall Agreement: 70.3% with the Orgentec Anti-Tg ELISA.
Comparable performance characteristics.	Shown through the 70.3% agreement in diagnosing autoimmune thyroid diseases.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 74 serum samples.
Data Provenance: The document states the samples were "from patients with Graves' disease, Hashimoto's thyroiditis and non-autoimmune thyroid disease." The country of origin is not specified, nor is whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document explicitly states that the ground truth for this comparison study was the results obtained from the predicate device, the Orgentec Anti-Tg ELISA (K952130). Therefore, no human experts were directly involved in establishing the ground truth for this particular comparison. The predicate device's performance established the reference.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" was the result from the predicate device; therefore, no expert adjudication was required or performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

Not applicable. This device is an in vitro diagnostic (IVD) assay, not an AI-assisted diagnostic tool or an imaging device requiring human interpretation. The study is a comparative effectiveness study between two IVD kits.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Yes, in the context of an IVD, the comparison study against the predicate device effectively functions as a standalone performance evaluation of the DYNOtest® anti-Tgn assay. It evaluates the kit's performance independently without human interpretation influencing the final result beyond conducting the assay.

7. The Type of Ground Truth Used

The ground truth used for the comparison study was the results obtained from the legally marketed predicate device, the Orgentec Anti-Tg ELISA (K952130). This functions as a "reference standard" rather than a clinical ground truth like pathology or expert consensus. Patients were characterized by their diagnoses (Graves', Hashimoto's, non-autoimmune thyroid disease), but the direct comparison was against the predicate's output.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/Machine Learning device that requires a separate training set. The study describes the validation of an IVD kit.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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NOV 1 2 1999

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 INFORMATIONDate of Summary Preparation:	October 15, 1999
Distributor:	BRAHMS Diagnostica, LLC29 South Peachtree StreetNorcross, Georgia 30092
Manufacturer:	BRAHMS Diagnostica, GmbHKomturstrasse 19-2012099 Berlin, Germany
Contact Person:	H. Lee HerronPartnerBRAHMS Diagnostica, LLC29 South Peachtree StreetNorcross, Georgia 30092Tel: 770-449-7738Fax: 770-449-7739
Device Name:	DYNOtest® anti-Tgₙ
Common or Usual Name:	Radioimmunoassay kit for the determination ofanti-thyroglobulin antibodies
Classification:Name:ClassCFR:	Thyroid autoantibody immunological test systemClass II21 CFR 866.5870
Substantial Equivalence To:	Orgentec Anti-Tg ELISA

II. INTENDED USE

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III. DEVICE DESCRIPTION

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
DYNOtestAnti-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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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 (770) 488-7655.

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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)

Over-The-Counter Use

Regulation Number and Section

§ 866.5870 Thyroid autoantibody immunological test system.

(a)
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.(b)
Classification. Class II (performance standards).