510(k) · Cleared
ClearedAtellica IM Thyroglobulin (Tg)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · MSW System, Test, Thyroglobulin
Cleared on Jun 20, 2025 as substantially equivalent to K241423 (Beckman Coulter, Inc., 2024) after a 267-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Jun 20, 2025
- Review
- 267 days
- Class
- Class II
- Product code
- MSW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002905 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK002905 Access Thyroglobulin Reagents on the Access AnalyzerBeckman Coulter, Inc. · 2000 · Recalled
- 2 generations backK220972 Access ThyroglobulinBeckman Coulter, Inc. · 2023
- 1 generation backK241423 Access ThyroglobulinBeckman Coulter, Inc. · 2024
- This deviceK242981 Atellica IM Thyroglobulin (Tg)Siemens Healthcare Diagnostics, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002905 | Access Thyroglobulin Reagents on the Access Analyzer | Beckman Coulter, Inc. | 2000 | 4 |
| −2 | K220972 | Access Thyroglobulin | Beckman Coulter, Inc. | 2023 | — |
| −1 | K241423 | Access Thyroglobulin | Beckman Coulter, Inc. | 2024 | — |
| 0 (this device) | K242981 | Atellica IM Thyroglobulin (Tg) | Siemens Healthcare Diagnostics, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K241423 | Access ThyroglobulinSummary page 6…Siemens Healthcare Diagnostics 510(k) Summary Regulation Number 21 CFR 866.6010 PREDICATE DEVICE Name of Device: Access Thyroglobulin 510(k): K241423 DEVICE DESCRIPTION The following devices are included in the Atellica® IM Thyroglobulin (Tg): Material Description Tg R… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 2 companies; a new generation was cleared every 1.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All MSW devicesMSW System, Test, Thyroglobulin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
The Atellica IM Thyroglobulin (Tg) assay is for in vitro diagnostic use in the quantitative measurement of thyroglobulin in human serum and plasma (EDTA and lithium heparin) using the Atellica IM Analyzer.
Thyroglobulin measurements are used as an aid in monitoring differentiated thyroid cancer patients who have undergone thyroidectomy with or without radioiodine ablation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242981 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242981: Atellica IM Thyroglobulin (Tg).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242981
Report an extraction error
Are you the manufacturer?
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