510(k) · Cleared
Recalled · Class II · 2020Roche Diagnostics Cobas Elecsys Anti-Tpo
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 Aug 4, 2005 as substantially equivalent to K000155 (Roche Diagnostics Corp., 2000) after a 23-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 4, 2005
- Review
- 23 days
- Class
- Class II
- Product code
- JZO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000155 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK000155 Elecsys Anti-Thyroid Peroxidase Antibody Test SystemRoche Diagnostics Corp. · 2000
- This deviceK051890 Roche Diagnostics Cobas Elecsys Anti-TpoRoche Diagnostics Corp. · 2005
- Descendant · cites it directly · 0 of its ownK103171 Elecsys Anti-Tpo CalsetRoche Diagnostics · 2011
Most influential descendants
Showing 1 of 1 · See all- K103171Elecsys Anti-Tpo CalsetRoche Diagnostics · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000155 | Elecsys Anti-Thyroid Peroxidase Antibody Test System | Roche Diagnostics Corp. | 2000 | — |
| 0 (this device) | K051890 | Roche Diagnostics Cobas Elecsys Anti-Tpo | Roche Diagnostics Corp. | 2005 | — |
| +1 | K103171 | Elecsys Anti-Tpo Calset | Roche Diagnostics | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K000155 | Elecsys Anti-Thyroid Peroxidase Antibody Test SystemSummary page 2…nti-TPO Test System is equivalent to other devices Device legally marketed in the United States. We claim equivalence to the Elecsys Anti-TPO (K000 155). Device The table below illustrates the similarities between the Elecsys Anti-TPO Comparison (K000155) and the… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103171 | Elecsys Anti-Tpo Calset | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 20, 2020 | Class II | Z-2981-2020 | Nonconforming Material/Component | Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K103171 (Roche Diagnostics, 2011) 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.
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?
The Elecsys Anti-TPO immunoassay is for the in vitro quantitative determination of antibodies to thyroid peroxidase in human serum and plasma. The anti-TPO determination is used as an aid in the diagnosis of autoimmune thyroid diseases.
The electrochemiluminescence immunoassay "ECLIA' is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051890 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051890: Roche Diagnostics Cobas Elecsys 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/K051890
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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