510(k) · Cleared
ClearedNichols Advantage Thyroglobulin Autoantibodies (Tgab) Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nichols Institute Diagnostics · JZO System, Test, Thyroid Autoantibody
Cleared on Jan 26, 1999 after a 78-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jan 26, 1999
- Review
- 78 days
- Class
- Class II
- Product code
- JZO
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK983992 Nichols Advantage Thyroglobulin Autoantibodies (Tgab) AssayNichols Institute Diagnostics · 1999
- Descendant · cites it directly · 0 of its ownK052308 Architect Anti-TG Immunoassay Reagents, Calibrators, Controls and…Fisher Diagnostics · 2006
Most influential descendants
Showing 1 of 1 · See all- K052308Architect Anti-TG Immunoassay Reagents, Calibrators, Controls and System Assay CD-RomFisher Diagnostics · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983992 | Nichols Advantage Thyroglobulin Autoantibodies (Tgab) Assay | Nichols Institute Diagnostics | 1999 | — |
| +1 | K052308 | Architect Anti-TG Immunoassay Reagents, Calibrators, Controls and System Assay… | Fisher Diagnostics | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 |
|---|---|---|---|
| * | — | Nichols Institute Diagnostics Chemiluminescence Thyroglobulin Autoantibodies assay Named without a submission number |
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 |
|---|---|---|---|
| K052308 | Architect Anti-TG Immunoassay Reagents, Calibrators, Controls and System Assay CD-Rom | 2006 | 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?
- Of its descendants, K052308 (Fisher Diagnostics, 2006) 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 Nichols Adventage® Chemiluminescence Thyroglobulin Autoantibodies Immunoassay is designed for use with the Nichols Advantage® Specialty System for the quantitative determination of thyroglobulin autoantibodies (TgAb) in human serum. This assay is intended to aid in the diagnosis and assessment of patients with autoimmune thyroid disease.
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/K983992 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983992: Nichols Advantage Thyroglobulin Autoantibodies (Tgab) Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983992
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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