510(k) · Cleared
Recalled · 2011Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and A36920 (Calibrators)
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 Oct 5, 2006 as substantially equivalent to K012208 (Beckman Coulter, Inc., 2001) after a 38-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 5, 2006
- Review
- 38 days
- Class
- Class II
- Product code
- JNL
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K012208 (2001). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK012208 Access Thyroglobulin Antibody and Calibrators on the Access…Beckman Coulter, Inc. · 2001 · Recalled
- This deviceK062516 Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and…Beckman Coulter, Inc. · 2006
- Descendant · cites it directly · 3 of its ownK112933 Access Thyroglobulin AnitbodyBeckman Coulter, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK213517 Access Thyroglobulin Antibody IIBeckman Coulter, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK250816 ADVIA Centaur Anti-Thyroglobulin II (aTgII)Siemens Healthcare Diagnostics, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK240996 Access Thyroglobulin Antibody IIBeckman Coulter, Inc. · 2024
Most influential descendants
Showing 4 of 4 · See all- K112933Access Thyroglobulin AnitbodyBeckman Coulter, Inc. · 2011 · cites it directly3descendants
- K213517Access Thyroglobulin Antibody IIBeckman Coulter, Inc. · 2023 · 2 generations on1descendant
- K250816ADVIA Centaur Anti-Thyroglobulin II (aTgII)Siemens Healthcare Diagnostics, Inc. · 2025 · 2 generations on0descendants
- K240996Access Thyroglobulin Antibody IIBeckman Coulter, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K012208 | Access Thyroglobulin Antibody and Calibrators on the Access Immunoassay… | Beckman Coulter, Inc. | 2001 | 1 |
| 0 (this device) | K062516 | Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and A36920… | Beckman Coulter, Inc. | 2006 | — |
| +1 | K112933 | Access Thyroglobulin Anitbody | Beckman Coulter, Inc. | 2011 | 2 |
| +2 | K213517 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | 2023 | — |
| +2 | K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | Siemens Healthcare Diagnostics, Inc. | 2025 | — |
| +3 | K240996 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 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
- #2 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 |
|---|---|---|---|
| * | K012208 | Access Thyroglobulin Antibody and Calibrators on the Access Immunoassay Systems, Models…Summary page 1…s II Product Code: Reagent- DDC Calibrator Secondary- JIT Predicate Device: Access® Thyroglobulin Antibody Assay - K012208 Device Description: The Access Thryoglobulin Antibody II reagents, calibrators, and the Acc… | 2001 |
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 |
|---|---|---|---|
| K112933 | Access Thyroglobulin Anitbody | 2011 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 26, 2011 | Not classified | Z-1818-2011 | Other | The recall was initiated after Beckman Coulter confirmed customer reports of reagent pack to pack variability for the Access Thyroglobulin Antibody II (TgAb) reagent lot numbers identified in the recall. Erroneous results for patient and… |
| Jun 29, 2010 | Not classified | Z-2355-2010 | Other | The affected Access Thyroglobulin Antibody II reagent may produce inaccurate results due to a change in the thyroglobulin that was used in the kits. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K112933 (Beckman Coulter, Inc., 2011) has gone furthest, with 3 descendants of its own.
How does its category compare?
All JNL devicesJNL Immunochemical, Thyroglobulin Autoantibody: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 provides in vitro 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/K062516 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062516: Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and A36920 (Calibrators).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062516
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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