# K021057: Brahms Diagnostica Dynotest TG-Plus

- Pathway: 510(k) (Traditional)
- Applicant: Brahms Diagnostica, LLC
- Decided: Sep 17, 2002 after 169 days
- Product code: MSW (System, Test, Thyroglobulin)
- Device class: 2
- Regulation: 21 CFR 866.6010
- 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 K994140 (2000). 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)
- K994140: Nichols Chemiluminescence Thyroglobulin, Model 60-4240, Nichols Institute Diagnostics (2000) Summary page 2.

## Indications for use
DYNOtest Tg-plus is a imunoradiometric assay (IRMA) for the quantitative determination of thyroglobulin in human serum It is intended to aid in the monitoring for the presence of local or metastatic thyroid tissue in patients who have had thyroid gland ablation (by surgery with or without radioiodine therapy). DYNOtest Tg-plus is also indicated for detecting the presence of thyroid tissue in patients with differentiated thyroid cancer when used with radioiodine whole body scans after recombinant thyrotropin (TSH) stimulation or thyroid hormone withdrawal. DYNOtest Tg-plus includes a recovery test to aid in the detection of interfering anti-thyroglobulin antibodies or other substances.

Source page: https://510kreport.com/device/K021057
Methodology: https://510kreport.com/methodology