510(k) · Cleared
ClearedBrahms Diagnostica Dynotest Anti-Tpo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brahms Diagnostica, LLC · JZO System, Test, Thyroid Autoantibody
Cleared on Nov 12, 1999 as substantially equivalent to K952129 (American Laboratory Products Co., Ltd., 1995) after an 85-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Nov 12, 1999
- Review
- 85 days
- Class
- Class II
- Product code
- JZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952129 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK952129 Orgentec Anti-Tpo ElisaAmerican Laboratory Products Co., Ltd. · 1995
- This deviceK992791 Brahms Diagnostica Dynotest Anti-TpoBrahms Diagnostica, LLC · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952129 | Orgentec Anti-Tpo Elisa | American Laboratory Products Co., Ltd. | 1995 | — |
| 0 (this device) | K992791 | Brahms Diagnostica Dynotest Anti-Tpo | Brahms Diagnostica, LLC | 1999 | — |
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 JZO? 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 JZO device
- #1 K250250 ADVIA Centaur Anti-Thyroid Peroxidase IIscore 10.5 · 2 generations · 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 |
|---|---|---|---|
| * | K952129 | Orgentec Anti-Tpo ElisaSummary page 2…of anti-thyroid peroxidase antibody in the sample. IV.COMPARISON TO PREDICATE DEVICE The DYNOtest® anti-TPO, immunoassay kit is similar to the Orgentec Anti-TPO ELISA (K952129) in the indications for use, performance characteristics and results. The DYNOtest anti-TPO,, test differs from the Orgentec Anti… | 1995 |
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 JZO devicesJZO System, Test, Thyroid Autoantibody: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JZO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JZO
Too few JZO 510(k)s in any year since 2007 to give a median.
Recalls per year · JZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JZO
44in 2025
MAUDE reports naming product code JZO, 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 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 2 | — | 0 | 8 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 35 |
| 2019 | 0 | — | 0 | 39 |
| 2020 | 1 | — | 0 | 17 |
| 2021 | 0 | — | 0 | 19 |
| 2022 | 0 | — | 0 | 25 |
| 2023 | 2 | — | 0 | 33 |
| 2024 | 1 | — | 0 | 29 |
| 2025 | 1 | — | 1 | 44 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992791 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992791: Brahms Diagnostica Dynotest Anti-Tpo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992791
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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