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 Jun 7, 2024 as substantially equivalent to K220972 (Beckman Coulter, Inc., 2023) after an 18-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Jun 7, 2024
- Review
- 18 days
- Class
- Class II
- Product code
- MSW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002905 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK002905 Access Thyroglobulin Reagents on the Access AnalyzerBeckman Coulter, Inc. · 2000 · Recalled
- 1 generation backK220972 Access ThyroglobulinBeckman Coulter, Inc. · 2023
- This deviceK241423 Access ThyroglobulinBeckman Coulter, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK242981 Atellica IM Thyroglobulin (Tg)Siemens Healthcare Diagnostics, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K242981Atellica IM Thyroglobulin (Tg)Siemens Healthcare Diagnostics, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002905 | Access Thyroglobulin Reagents on the Access Analyzer | Beckman Coulter, Inc. | 2000 | 4 |
| −1 | K220972 | Access Thyroglobulin | Beckman Coulter, Inc. | 2023 | — |
| 0 (this device) | K241423 | Access Thyroglobulin | Beckman Coulter, Inc. | 2024 | — |
| +1 | K242981 | Atellica IM Thyroglobulin (Tg) | Siemens Healthcare Diagnostics, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 K220972 Access Thyroglobulinscore 12.0 · 1 generation · 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 |
|---|---|---|---|
| * | K220972 | Access ThyroglobulinSummary page 5…=== Predicate Device: The modified Access Thyroglobulin assay claims substantial equivalence to previously cleared Access Thyroglobulin assay, FDA 510(k) Number K220972, cleared September 15, 2023. Device Description: The Access Thyroglobulin assay consists of the reagent pack and calibrato… | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242981 | Atellica IM Thyroglobulin (Tg) | 2025 | 0 |
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 24 years and passes through 1 company; a new generation was cleared every 22.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K242981 (Siemens Healthcare Diagnostics, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K220972.
How does its category compare?
All MSW devicesMSW System, Test, Thyroglobulin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 and plasma 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/K241423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241423: Access Thyroglobulin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241423
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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