510(k) · Cleared
ClearedAccess Thyroglobulin Antibody II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JZO System, Test, Thyroid Autoantibody
Cleared on Sep 26, 2023 as substantially equivalent to K112933 (Beckman Coulter, Inc., 2011) after a 692-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- Sep 26, 2023
- Review
- 692 days
- Class
- Class II
- Product code
- JZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K012208 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK012208 Access Thyroglobulin Antibody and Calibrators on the Access…Beckman Coulter, Inc. · 2001 · Recalled
- 2 generations backK062516 Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and…Beckman Coulter, Inc. · 2006 · Recalled
- 1 generation backK112933 Access Thyroglobulin AnitbodyBeckman Coulter, Inc. · 2011 · Recalled
- This deviceK213517 Access Thyroglobulin Antibody IIBeckman Coulter, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK240996 Access Thyroglobulin Antibody IIBeckman Coulter, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240996Access Thyroglobulin Antibody IIBeckman Coulter, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K012208 | Access Thyroglobulin Antibody and Calibrators on the Access Immunoassay… | Beckman Coulter, Inc. | 2001 | 1 |
| −2 | K062516 | Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and A36920… | Beckman Coulter, Inc. | 2006 | 2 |
| −1 | K112933 | Access Thyroglobulin Anitbody | Beckman Coulter, Inc. | 2011 | 2 |
| 0 (this device) | K213517 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | 2023 | — |
| +1 | K240996 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K112933 | Access Thyroglobulin AnitbodySummary page 5…odified Access Thyroglobulin Antibody II Assay claims substantial equivalence to previously cleared Access Thyroglobulin Antibody II Assay, FDA 510(k) Number K112933, cleared December 27, 2011. Device Description: The Access Thyroglobulin Antibody II assay is a paramagnetic particle,… | 2011 |
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 |
|---|---|---|---|
| K240996 | Access Thyroglobulin Antibody II | 2024 | 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 22 years and passes through 1 company; a new generation was cleared every 5.2 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K240996 (Beckman Coulter, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K112933.
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?
The Access Thyroglobulin Antibody II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213517 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213517: Access Thyroglobulin Antibody II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213517
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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