510(k) · Cleared
ClearedBrahms Diagnostica Dynotest TG-Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brahms Diagnostica, LLC · MSW System, Test, Thyroglobulin
Cleared on Sep 17, 2002 as substantially equivalent to K994140 (Nichols Institute Diagnostics, 2000) after a 169-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Sep 17, 2002
- Review
- 169 days
- Class
- Class II
- Product code
- MSW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K994140 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK994140 Nichols Chemiluminescence Thyroglobulin, Model 60-4240Nichols Institute Diagnostics · 2000
- This deviceK021057 Brahms Diagnostica Dynotest TG-PlusBrahms Diagnostica, LLC · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K994140 | Nichols Chemiluminescence Thyroglobulin, Model 60-4240 | Nichols Institute Diagnostics | 2000 | — |
| 0 (this device) | K021057 | Brahms Diagnostica Dynotest TG-Plus | Brahms Diagnostica, LLC | 2002 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MSW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MSW device
- #1 K220972 Access Thyroglobulinscore 12.0 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K994140 | Nichols Chemiluminescence Thyroglobulin, Model 60-4240Summary page 2…CATE DEVICE Comparison to predicate device: DYNOtest Tg-plus is substantially equivalent to the Nichols Institute Diagnostics Chemiluminescent Thyroglobulin assay (E994140). The following method comparison study included 133 samples from patients diagnosed with thyroid cancer. Concordance testing… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All MSW devicesMSW System, Test, Thyroglobulin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSW
Too few MSW 510(k)s in any year since 2007 to give a median.
Recalls per year · MSW
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSW
3in 2025
MAUDE reports naming product code MSW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 57 |
| 2023 | 2 | — | 1 | 4 |
| 2024 | 2 | — | 0 | 3 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021057: Brahms Diagnostica Dynotest TG-Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021057
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026