# K992790: Brahms Diagnostica Dynotest Anti-TG

- Pathway: 510(k) (Traditional)
- Applicant: Brahms Diagnostica, LLC
- Decided: Nov 12, 1999 after 85 days
- Product code: JZO (System, Test, Thyroid Autoantibody)
- Device class: 2
- Regulation: 21 CFR 866.5870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K952130 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952130: Orgentec Anti-TG Elisa, American Laboratory Products Co., Ltd. (1995) Summary page 2.

## Most influential descendants
- K012777: Acs: 180 and Advia Centaur Anti-Thyroglobulin Immunoassays (2001), 0 descendants of its own

## 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 techmque. The DYNOtest anti-Tg, kit is used as an aid in the diagnosis of Hashimoto’s thyroiditis and Graves’ disease, autoimmmune discases affecting the thyroid gland.

Source page: https://510kreport.com/device/K992790
Methodology: https://510kreport.com/methodology