510(k) · Cleared
ClearedElecsys Anti-TSHR Immunoassay, Elecsys Precicontrol Thyroab
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · JZO System, Test, Thyroid Autoantibody
Cleared on Jul 28, 2008 as substantially equivalent to K033454 (Brahms Diagnostica, LLC, 2004) after a 196-day review. Its family tree reaches back 1 generation to 2004. 3 later devices descend from it.
- Decided
- Jul 28, 2008
- Review
- 196 days
- Class
- Class II
- Product code
- JZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K033454 (2004). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK033454 Brahms Diagnostica Lumitest Trak HumanBrahms Diagnostica, LLC · 2004
- This deviceK080092 Elecsys Anti-TSHR Immunoassay, Elecsys Precicontrol ThyroabRoche Diagnostics Corp. · 2008
- Descendant · cites it directly · 0 of its ownK193313 Elecsys Anti-TSHRRoche Diagnostics · 2020 · Recalled
- Descendant · cites it directly · 0 of its ownK152061 IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2016 · Recalled
- Descendant · cites it directly · 0 of its ownK092320 Elecsys Precicontrol ThyroabRoche Diagnostics · 2009
Most influential descendants
Showing 3 of 3 · See all- K193313Elecsys Anti-TSHRRoche Diagnostics · 2020 · cites it directly0descendants
- K152061IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2016 · cites it directly0descendants
- K092320Elecsys Precicontrol ThyroabRoche Diagnostics · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033454 | Brahms Diagnostica Lumitest Trak Human | Brahms Diagnostica, LLC | 2004 | — |
| 0 (this device) | K080092 | Elecsys Anti-TSHR Immunoassay, Elecsys Precicontrol Thyroab | Roche Diagnostics Corp. | 2008 | — |
| +1 | K193313 | Elecsys Anti-TSHR | Roche Diagnostics | 2020 | 1 |
| +1 | K152061 | IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2016 | 1 |
| +1 | K092320 | Elecsys Precicontrol Thyroab | Roche Diagnostics | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
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 |
|---|---|---|---|
| * | K033454 | Brahms Diagnostica Lumitest Trak HumanSummary page 2…equivalence following cleared device: (1) Elecsys Anti-TSHR Immunoassay is equivalent to the BRAHMS LUMItest TRAK human Assay (K033454). Both products are intended for use in the quantitative determination of autoantibodies to TSH receptor in… | 2004 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- Of its descendants, K193313 (Roche Diagnostics, 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JZO devicesJZO System, Test, Thyroid Autoantibody: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
Immunoassay for the in vitro quantitative determination of autoantibodies to TSH receptor in human serum using a human thyroid stimulating monoclonal antibody. The anti-TSH receptor determination is used in the assessment of patients with suspect Graves' disease (autoimmune hyperthyroidism).
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Elecsys PreciControl ThyroAB is used for quality control of the Elecsys Anti-TSHR immunoassay on the Elecsys and cobas e immuinoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080092 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080092: Elecsys Anti-TSHR Immunoassay, Elecsys Precicontrol Thyroab.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080092
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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