510(k) · Cleared
ClearedImmulite Anti-TG AB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · JZO System, Test, Thyroid Autoantibody
Cleared on May 1, 1998 as substantially equivalent to K950090 (American Laboratory Products Co., Ltd., 1995) after a 101-day review. Its family tree reaches back 1 generation to 1995. 4 later devices descend from it.
- Decided
- May 1, 1998
- Review
- 101 days
- Class
- Class II
- Product code
- JZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950090 (1995). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK950090 Orgentec Anti-Tpo Pia (Pin Immuno Assay)American Laboratory Products Co., Ltd. · 1995
- This deviceK980206 Immulite Anti-TG ABDiagnostic Products Corp. · 1998
- Descendant · cites it directly · 3 of its ownK991094 Immulite 2000 Anti-TG AB, Model L2KTG2, L2KTG6Diagnostic Products Corp. · 1999 · Recalled
- Descendant · 2 generations on · 2 of its ownK020672 Elecsys Anti-TG Test SystemRoche Diagnostics Corp. · 2002
- Descendant · 3 generations on · 1 of its ownK053426 Roche Elecsys Anti-TGRoche Diagnostics Corp. · 2006
- Descendant · 4 generations on · 0 of its ownK222610 Elecsys Anti-TgRoche Diagnostics · 2023
Most influential descendants
Showing 4 of 4 · See all- K991094Immulite 2000 Anti-TG AB, Model L2KTG2, L2KTG6Diagnostic Products Corp. · 1999 · cites it directly3descendants
- K020672Elecsys Anti-TG Test SystemRoche Diagnostics Corp. · 2002 · 2 generations on2descendants
- K053426Roche Elecsys Anti-TGRoche Diagnostics Corp. · 2006 · 3 generations on1descendant
- K222610Elecsys Anti-TgRoche Diagnostics · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950090 | Orgentec Anti-Tpo Pia (Pin Immuno Assay) | American Laboratory Products Co., Ltd. | 1995 | — |
| 0 (this device) | K980206 | Immulite Anti-TG AB | Diagnostic Products Corp. | 1998 | — |
| +1 | 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 | — |
| +3 | K053426 | Roche Elecsys Anti-TG | Roche Diagnostics Corp. | 2006 | — |
| +4 | K222610 | Elecsys Anti-Tg | Roche Diagnostics | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K950090 | Orgentec Anti-Tpo Pia (Pin Immuno Assay)Summary page 2…Los Angeles, California 90045-5597 EURO/DPC: Not Applicable DPC: 2017183 Substantially Equivalent Predicate Device: ORGenTec Anti-TG PIN Immuno Assay (K950090) Manufactured by ORGenTec, and distibuted in the USA by ALPCO, Windham, NH Description of Device: IMMULITE® Anti-TG Ab is a clin… | 1995 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991094 | Immulite 2000 Anti-TG AB, Model L2KTG2, L2KTG6 | 1999 | 3 |
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?
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?
IMMULITE® Anti-TG Ab is a solid-phase, two-step chemiluminescent enzyme immunometric assay for use with the IMMULITE® Automated Immunoassay Analyzer and designed for the quantitative measurement of antibodies against thyroglobulin (TG) in serum, EDTA, heparinized, and citrate plasma. It is intended strictly for in vitro diagnostic use as an aid in the clinical diagnosis of thyroid diseases.
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/K980206 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980206: Immulite Anti-TG AB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980206
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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