510(k) · Cleared
Recalled · Class II · 2024Immulite 2000 Anti-TG AB, Model L2KTG2, L2KTG6
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 13, 1999 as substantially equivalent to K980206 (Diagnostic Products Corp., 1998) after a 42-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- May 13, 1999
- Review
- 42 days
- Class
- Class II
- Product code
- JZO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950090 (1995). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK950090 Orgentec Anti-Tpo Pia (Pin Immuno Assay)American Laboratory Products Co., Ltd. · 1995
- 1 generation backK980206 Immulite Anti-TG ABDiagnostic Products Corp. · 1998
- This deviceK991094 Immulite 2000 Anti-TG AB, Model L2KTG2, L2KTG6Diagnostic Products Corp. · 1999
- Descendant · cites it directly · 2 of its ownK020672 Elecsys Anti-TG Test SystemRoche Diagnostics Corp. · 2002
- Descendant · 2 generations on · 1 of its ownK053426 Roche Elecsys Anti-TGRoche Diagnostics Corp. · 2006
- Descendant · 3 generations on · 0 of its ownK222610 Elecsys Anti-TgRoche Diagnostics · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950090 | Orgentec Anti-Tpo Pia (Pin Immuno Assay) | American Laboratory Products Co., Ltd. | 1995 | — |
| −1 | K980206 | Immulite Anti-TG AB | Diagnostic Products Corp. | 1998 | — |
| 0 (this device) | K991094 | Immulite 2000 Anti-TG AB, Model L2KTG2, L2KTG6 | Diagnostic Products Corp. | 1999 | — |
| +1 | K020672 | Elecsys Anti-TG Test System | Roche Diagnostics Corp. | 2002 | — |
| +2 | K053426 | Roche Elecsys Anti-TG | Roche Diagnostics Corp. | 2006 | — |
| +3 | K222610 | Elecsys Anti-Tg | Roche Diagnostics | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K980206 | Immulite Anti-TG ABSummary page 1…vice, 82-JZ0 (21CFR 866.5870) Diagnostic Products Corporation 5700 West 96 Street Los Angeles, CA 90045-5597 DPC Registration number is 2017183 IMMULITE”™ Anti-TG Ab (K980206) IMMULITE® 2000 Anti-TG Ab is a clinical use device intended for use with the IMMULITE® 2000 Automated Immunoassay Analyzer I3… | 1998 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020672 | Elecsys Anti-TG Test System | 2002 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 23, 2024 | Class II | Z-1886-2024 | Under Investigation by firm | The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of IMMULITE 2000 Anti-TG Ab. |
| Apr 23, 2024 | Class II | Z-1887-2024 | Under Investigation by firm | The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791, and 793) of IMMULITE 2000 Anti-TG Ab. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K020672 (Roche Diagnostics Corp., 2002) has gone furthest, with 2 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?
IMMULITE 2000 Anti-TG Ab is for in vitro diagnostic use with the IMMULITE 2000 Analyzer for the quantitative measurement of autoantibodies to thyroglobulin (TG) in serum, EDTA, and heparinized plasma, 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/K991094 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991094: Immulite 2000 Anti-TG AB, Model L2KTG2, L2KTG6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991094
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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