510(k) · Cleared
ClearedAccess Thyroglobulin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · MSW System, Test, Thyroglobulin
Cleared on Sep 15, 2023 as substantially equivalent to K002905 (Beckman Coulter, Inc., 2000) after a 529-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.
- Decided
- Sep 15, 2023
- Review
- 529 days
- Class
- Class II
- Product code
- MSW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002905 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK002905 Access Thyroglobulin Reagents on the Access AnalyzerBeckman Coulter, Inc. · 2000 · Recalled
- This deviceK220972 Access ThyroglobulinBeckman Coulter, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK241423 Access ThyroglobulinBeckman Coulter, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK242981 Atellica IM Thyroglobulin (Tg)Siemens Healthcare Diagnostics, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK240927 Access ThyroglobulinBeckman Coulter, Inc. · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002905 | Access Thyroglobulin Reagents on the Access Analyzer | Beckman Coulter, Inc. | 2000 | 4 |
| 0 (this device) | K220972 | Access Thyroglobulin | Beckman Coulter, Inc. | 2023 | — |
| +1 | K241423 | Access Thyroglobulin | Beckman Coulter, Inc. | 2024 | — |
| +2 | K242981 | Atellica IM Thyroglobulin (Tg) | Siemens Healthcare Diagnostics, Inc. | 2025 | — |
| +1 | K240927 | Access Thyroglobulin | Beckman Coulter, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 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 MSW? 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 MSW device
- #1 K241423 Access Thyroglobulinscore 10.8 · 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 |
|---|---|---|---|
| * | K002905 | Access Thyroglobulin Reagents on the Access AnalyzerSummary page 5…cate Device: The modified Access Thyroglobulin assay claims substantial equivalence to previously cleared Access Thyroglobulin assay, FDA 510(k) Number K002905, cleared October 19, 2000. Device Description: Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent… | 2000 |
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MSW devicesMSW System, Test, Thyroglobulin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MSW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSW
Too few MSW 510(k)s in any year since 2007 to give a median.
Recalls per year · MSW
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSW
3in 2025
MAUDE reports naming product code MSW, 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 | — | 1 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 57 |
| 2023 | 2 | — | 1 | 4 |
| 2024 | 2 | — | 0 | 3 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum using the Access Immunoassay Systems. This device is intended to aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thyroglobulin antibodies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220972 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220972: Access Thyroglobulin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220972
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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