# K992791: Brahms Diagnostica Dynotest Anti-Tpo

- 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 K952129 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952129: Orgentec Anti-Tpo Elisa, American Laboratory Products Co., Ltd. (1995) Summary page 2.

## Indications for use
DYNOtest anti-TPO, is a competitive radioimmunoassay for the quantitative determination of autoantibodies to thyroid peroxidase (TPO) in human serum using the coated tube technique. The DYNOtest anti-TPO, kit is used as an aid in the diagnosis of Hashimoto’s thyroiditis and Graves’ disease, autoimmune diseases affecting the thyroid gland.

Source page: https://510kreport.com/device/K992791
Methodology: https://510kreport.com/methodology