510(k) · Cleared
Recalled · 2006Access Thyroglobulin Antibody and Calibrators on the Access Immunoassay Systems, Models 33890, 33895
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · DDC Thyroglobulin, Antigen, Antiserum, Control
Cleared on Sep 7, 2001 after a 53-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 5 later devices descend from it. It has been recalled once.
- Decided
- Sep 7, 2001
- Review
- 53 days
- Class
- Class II
- Product code
- DDC
- Recalls
- 1
- Predicates
- 1
5 later devices descend from it, 1 citing it directly.
- This deviceK012208 Access Thyroglobulin Antibody and Calibrators on the Access…Beckman Coulter, Inc. · 2001
- Descendant · cites it directly · 4 of its ownK062516 Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and…Beckman Coulter, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 3 of its ownK112933 Access Thyroglobulin AnitbodyBeckman Coulter, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 1 of its ownK213517 Access Thyroglobulin Antibody IIBeckman Coulter, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK250816 ADVIA Centaur Anti-Thyroglobulin II (aTgII)Siemens Healthcare Diagnostics, Inc. · 2025
- Descendant · 4 generations on · 0 of its ownK240996 Access Thyroglobulin Antibody IIBeckman Coulter, Inc. · 2024
Most influential descendants
Showing 5 of 5 · See all- K062516Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and A36920 (Calibrators)Beckman Coulter, Inc. · 2006 · cites it directly4descendants
- K112933Access Thyroglobulin AnitbodyBeckman Coulter, Inc. · 2011 · 2 generations on3descendants
- K213517Access Thyroglobulin Antibody IIBeckman Coulter, Inc. · 2023 · 3 generations on1descendant
- K250816ADVIA Centaur Anti-Thyroglobulin II (aTgII)Siemens Healthcare Diagnostics, Inc. · 2025 · 3 generations on0descendants
- K240996Access Thyroglobulin Antibody IIBeckman Coulter, Inc. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012208 | Access Thyroglobulin Antibody and Calibrators on the Access Immunoassay… | Beckman Coulter, Inc. | 2001 | — |
| +1 | 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 |
| +3 | K213517 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | 2023 | — |
| +3 | K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | Siemens Healthcare Diagnostics, Inc. | 2025 | — |
| +4 | K240996 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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 DDC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K834203 | FDA’s K834203 is Flexxr* CPM System Our OCR of the scanned summary read K834203, FDA’s number for Flexxr* CPM System (Qarex Laboratories, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Kalibre-R™ Thyroglobulin Antibody (TgAb) RIA Kit”. Kept off the family tree. Summary page 1…unochemical, Thyroglobulin Autoantibody Predicate Device Kalibre-R™ Thyroglobulin Antibody (TgAb) RIA Kit Kronus / Boise Research Center Boise, ID 83713 510(k) Number: K834203 Device Description The Access Thyroglobulin Antibody reagents, Thyroglobulin Antibody calibrators, and the Access Immunoassay An… | 1984 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062516 | Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and A36920 (Calibrators) | 2006 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 26, 2006 | Not classified | Z-0417-2007 | Other | Low end imprecision affecting both S0 calibrators and patient samples which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K062516 (Beckman Coulter, Inc., 2006) has gone furthest, with 4 descendants of its own.
How does its category compare?
All DDC devicesDDC Thyroglobulin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DDC
FDA has decided no DDC device since 2007.
Median 510(k) review, days · DDC
Too few DDC 510(k)s in any year since 2007 to give a median.
Recalls per year · DDC
No recall names DDC since 2007.
Adverse event reports per year · DDC
1in 2023
MAUDE reports naming product code DDC, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Access Thyroglobulin Antibody (TgAb) 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 certain thyroid disorders, such as Hashimoto’s disease, nontoxic goiter, and Graves ‘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/K012208 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012208: Access Thyroglobulin Antibody and Calibrators on the Access Immunoassay Systems, Models 33890, 33895.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012208
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026