510(k) · Cleared
ClearedRoche Elecsys Anti-TG
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 Feb 7, 2006 as substantially equivalent to K020672 (Roche Diagnostics Corp., 2002) after a 61-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Feb 7, 2006
- Review
- 61 days
- Class
- Class II
- Product code
- JZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K950090 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK950090 Orgentec Anti-Tpo Pia (Pin Immuno Assay)American Laboratory Products Co., Ltd. · 1995
- 3 generations backK980206 Immulite Anti-TG ABDiagnostic Products Corp. · 1998
- 2 generations backK991094 Immulite 2000 Anti-TG AB, Model L2KTG2, L2KTG6Diagnostic Products Corp. · 1999 · Recalled
- 1 generation backK020672 Elecsys Anti-TG Test SystemRoche Diagnostics Corp. · 2002
- This deviceK053426 Roche Elecsys Anti-TGRoche Diagnostics Corp. · 2006
- Descendant · cites it directly · 0 of its ownK222610 Elecsys Anti-TgRoche Diagnostics · 2023
Most influential descendants
Showing 1 of 1 · See all- K222610Elecsys Anti-TgRoche Diagnostics · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K950090 | Orgentec Anti-Tpo Pia (Pin Immuno Assay) | American Laboratory Products Co., Ltd. | 1995 | — |
| −3 | K980206 | Immulite Anti-TG AB | Diagnostic Products Corp. | 1998 | — |
| −2 | K991094 | Immulite 2000 Anti-TG AB, Model L2KTG2, L2KTG6 | Diagnostic Products Corp. | 1999 | 2 |
| −1 | K020672 | Elecsys Anti-TG Test System | Roche Diagnostics Corp. | 2002 | — |
| 0 (this device) | K053426 | Roche Elecsys Anti-TG | Roche Diagnostics Corp. | 2006 | — |
| +1 | K222610 | Elecsys Anti-Tg | Roche Diagnostics | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K020672 | Elecsys Anti-TG Test SystemSummary page 2…s. Predicate The Elecsys Anti-Tg is equivalent to other devices legally marketed in the device United States. We claim equivalence to the Elecsys Anti-Tg (K020672). Continued on next page Confidential… | 2002 |
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 |
|---|---|---|---|
| K222610 | Elecsys Anti-Tg | 2023 | 0 |
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 11 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K222610 (Roche Diagnostics, 2023) 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?
Immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma. The anti-Tg determination is used as an aid in the detection of autoimmune thyroid diseases. The electrochemiluminescence Immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E 170 (Elecsys module) immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053426 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053426: Roche Elecsys Anti-TG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053426
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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