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. · JNL Immunochemical, Thyroglobulin Autoantibody
Cleared on Jul 3, 2024 as substantially equivalent to K213517 (Beckman Coulter, Inc., 2023) after an 83-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Jul 3, 2024
- Review
- 83 days
- Class
- Class II
- Product code
- JNL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K012208 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK012208 Access Thyroglobulin Antibody and Calibrators on the Access…Beckman Coulter, Inc. · 2001 · Recalled
- 3 generations backK062516 Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and…Beckman Coulter, Inc. · 2006 · Recalled
- 2 generations backK112933 Access Thyroglobulin AnitbodyBeckman Coulter, Inc. · 2011 · Recalled
- 1 generation backK213517 Access Thyroglobulin Antibody IIBeckman Coulter, Inc. · 2023
- This deviceK240996 Access Thyroglobulin Antibody IIBeckman Coulter, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K012208 | Access Thyroglobulin Antibody and Calibrators on the Access Immunoassay… | Beckman Coulter, Inc. | 2001 | 1 |
| −3 | K062516 | Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and A36920… | Beckman Coulter, Inc. | 2006 | 2 |
| −2 | K112933 | Access Thyroglobulin Anitbody | Beckman Coulter, Inc. | 2011 | 2 |
| −1 | K213517 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | 2023 | — |
| 0 (this device) | K240996 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | 2024 | — |
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 JNL? 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 JNL device
- #1 K250816 ADVIA Centaur Anti-Thyroglobulin II (aTgII)score 11.1 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K213517 | Access Thyroglobulin Antibody IISummary page 4…test system. Classification Regulation: 21 CFR 866.5870 Classification Product Code: JNL Predicate Device Device Name: Access Thyroglobulin Antibody II 510(k) Numbers: K213517 Device Description The Access Thyroglobulin Antibody II assay is a paramagnetic particle, chemiluminescent immunoassay for the q… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 1 company; a new generation was cleared every 5.2 years on median.
- 3 of the 4 ancestors have a recall of any class.
How does its category compare?
All JNL devicesJNL Immunochemical, Thyroglobulin Autoantibody: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · JNL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JNL
Too few JNL 510(k)s in any year since 2007 to give a median.
Recalls per year · JNL
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JNL
1in 2025
MAUDE reports naming product code JNL, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 1 | 0 |
| 2025 | 1 | — | 0 | 1 |
| 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/K240996 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240996: 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/K240996
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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