510(k) · Cleared
ClearedElecsys Anti-Tg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · JZO System, Test, Thyroid Autoantibody
Cleared on Sep 15, 2023 as substantially equivalent to K053426 (Roche Diagnostics Corp., 2006) after a 382-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Sep 15, 2023
- Review
- 382 days
- Class
- Class II
- Product code
- JZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K950090 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK950090 Orgentec Anti-Tpo Pia (Pin Immuno Assay)American Laboratory Products Co., Ltd. · 1995
- 4 generations backK980206 Immulite Anti-TG ABDiagnostic Products Corp. · 1998
- 3 generations backK991094 Immulite 2000 Anti-TG AB, Model L2KTG2, L2KTG6Diagnostic Products Corp. · 1999 · Recalled
- 2 generations backK020672 Elecsys Anti-TG Test SystemRoche Diagnostics Corp. · 2002
- 1 generation backK053426 Roche Elecsys Anti-TGRoche Diagnostics Corp. · 2006
- This deviceK222610 Elecsys Anti-TgRoche Diagnostics · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K950090 | Orgentec Anti-Tpo Pia (Pin Immuno Assay) | American Laboratory Products Co., Ltd. | 1995 | — |
| −4 | K980206 | Immulite Anti-TG AB | Diagnostic Products Corp. | 1998 | — |
| −3 | K991094 | Immulite 2000 Anti-TG AB, Model L2KTG2, L2KTG6 | Diagnostic Products Corp. | 1999 | 2 |
| −2 | K020672 | Elecsys Anti-TG Test System | Roche Diagnostics Corp. | 2002 | — |
| −1 | K053426 | Roche Elecsys Anti-TG | Roche Diagnostics Corp. | 2006 | — |
| 0 (this device) | K222610 | Elecsys Anti-Tg | Roche Diagnostics | 2023 | — |
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 |
|---|---|---|---|
| * | K053426 | Roche Elecsys Anti-TGSummary page 4…Thyroid Autoantibody Product Codes, JZO, 21 CFR 866.5870 Regulation Numbers Predicate Devices Roche Diagnostics Elecsys Anti-Tg (K053426) Roche Diagnostics GmbH Mannheim, Germany: 9610126 Establishment Registration Roche Diagnostics Gm… | 2006 |
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?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All JZO devicesJZO System, Test, Thyroid Autoantibody: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 antibodies to thyroglobulin in human serum and plasma. The anti‑Tg autoantibodies determination is used as an aid in the detection of autoimmune thyroid diseases in conjunction with other laboratory and clinical findings.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e 411 immunoassay analyzer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222610 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222610: Elecsys Anti-Tg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222610
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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