(85 days)
No
The description details a traditional radioimmunoassay (RIA) technique based on competitive binding and radioactivity measurement. There is no mention of AI, ML, or any computational analysis beyond basic quantitative determination based on the inverse relationship between radioactivity and antibody quantity.
No
This device is a diagnostic aid, designed to measure autoantibodies for diagnosis, not to treat a condition.
Yes
The device is explicitly stated to be "used as an aid in the diagnosis of Hashimoto's thyroiditis and Graves' disease."
No
The device description clearly states it is a competitive radioimmunoassay (RIA) using a coated tube technique and involves measuring radioactivity. This indicates a physical kit with reagents and hardware components, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of autoantibodies against thyroglobulin (Tg) in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body).
- Aid in Diagnosis: The kit is used as an "aid in the diagnosis of Hashimoto's thyroiditis and Graves' disease." This is a key characteristic of IVDs – they provide information to help diagnose medical conditions.
- Device Description: The description details a laboratory test (radioimmunoassay) performed on a biological sample (human sera) to measure a specific analyte (autoantibodies against thyroglobulin). This is the core function of an IVD.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
JZO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Overall agreement based on a 2 X 2 agreement table was 52/74 = 70.3%.
% Agreement = 70.3%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
| Date of Summary Preparation: | October 15, 1999 |
|---|---|
| Distributor: | BRAHMS Diagnostica, LLC |
| 29 South Peachtree Street | |
| Norcross, Georgia 30092 | |
| Manufacturer: | BRAHMS Diagnostica, GmbH |
| Komturstrasse 19-20 | |
| 12099 Berlin, Germany | |
| Contact Person: | H. Lee Herron |
| Partner | |
| BRAHMS Diagnostica, LLC | |
| 29 South Peachtree Street | |
| Norcross, Georgia 30092 | |
| Tel: 770-449-7738 | |
| Fax: 770-449-7739 | |
| Device Name: | DYNOtest® anti-Tgₙ |
| Common or Usual Name: | Radioimmunoassay kit for the determination of |
| anti-thyroglobulin antibodies | |
| Classification: | |
| Name: | |
| Class | |
| CFR: | Thyroid autoantibody immunological test system |
| Class II | |
| 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.
1
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 | |||
| 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 (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
4
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)
OR
Over-The-Counter Use