510(k) · Cleared
Recalled · Class II · 2024Access Thyroglobulin Anitbody
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 Dec 27, 2011 as substantially equivalent to K062516 (Beckman Coulter, Inc., 2006) after an 85-day review. Its family tree reaches back 2 generations to 2001. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 27, 2011
- Review
- 85 days
- Class
- Class II
- Product code
- JNL
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K012208 (2001). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK012208 Access Thyroglobulin Antibody and Calibrators on the Access…Beckman Coulter, Inc. · 2001 · Recalled
- 1 generation backK062516 Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and…Beckman Coulter, Inc. · 2006 · Recalled
- This deviceK112933 Access Thyroglobulin AnitbodyBeckman Coulter, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK213517 Access Thyroglobulin Antibody IIBeckman Coulter, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK250816 ADVIA Centaur Anti-Thyroglobulin II (aTgII)Siemens Healthcare Diagnostics, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK240996 Access Thyroglobulin Antibody IIBeckman Coulter, Inc. · 2024
Most influential descendants
Showing 3 of 3 · See all- K213517Access Thyroglobulin Antibody IIBeckman Coulter, Inc. · 2023 · cites it directly1descendant
- K250816ADVIA Centaur Anti-Thyroglobulin II (aTgII)Siemens Healthcare Diagnostics, Inc. · 2025 · cites it directly0descendants
- K240996Access Thyroglobulin Antibody IIBeckman Coulter, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K012208 | Access Thyroglobulin Antibody and Calibrators on the Access Immunoassay… | Beckman Coulter, Inc. | 2001 | 1 |
| −1 | K062516 | Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and A36920… | Beckman Coulter, Inc. | 2006 | 2 |
| 0 (this device) | K112933 | Access Thyroglobulin Anitbody | Beckman Coulter, Inc. | 2011 | — |
| +1 | K213517 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | 2023 | — |
| +1 | K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | Siemens Healthcare Diagnostics, Inc. | 2025 | — |
| +2 | K240996 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K062516 | Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and A36920 (Calibrators)Summary page 1…oglobulin Antibody Enzyme Immunoassay Classification Name: Immunochemnical, Thyroglobulin Autoantibody Predicate Device Access Thyroglobulin Antibody 11(k062516) Manufactured by Beckman Coulter, Inc. Device Description The Access Thyroglobulin Antibody 1… | 2006 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 5, 2024 | Class II | Z-0265-2025 | Error in labeling | IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results. |
| Apr 30, 2019 | Class II | Z-2242-2020 | Other | The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 5.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K213517 (Beckman Coulter, Inc., 2023) has gone furthest, with 1 descendant 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. 2011, 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 11 assay is a paramagnetic 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/K112933 · printed Nov 4, 2026
Cite this page
510(k) Report. “K112933: Access Thyroglobulin Anitbody.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K112933
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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