510(k) · Cleared
Recalled · Class II · 2019Access Thyroglobulin Reagents on the Access Analyzer
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 Oct 19, 2000 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 19, 2000
- Review
- 31 days
- Class
- Class II
- Product code
- MSW
- Recalls
- 4
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK002905 Access Thyroglobulin Reagents on the Access AnalyzerBeckman Coulter, Inc. · 2000
- Descendant · cites it directly · 3 of its ownK220972 Access ThyroglobulinBeckman Coulter, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK241423 Access ThyroglobulinBeckman Coulter, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK242981 Atellica IM Thyroglobulin (Tg)Siemens Healthcare Diagnostics, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK240927 Access ThyroglobulinBeckman Coulter, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK221890 Elecsys Tg IIRoche Diagnostics · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K220972Access ThyroglobulinBeckman Coulter, Inc. · 2023 · cites it directly3descendants
- K241423Access ThyroglobulinBeckman Coulter, Inc. · 2024 · 2 generations on1descendant
- K242981Atellica IM Thyroglobulin (Tg)Siemens Healthcare Diagnostics, Inc. · 2025 · 3 generations on0descendants
- K240927Access ThyroglobulinBeckman Coulter, Inc. · 2024 · 2 generations on0descendants
- K221890Elecsys Tg IIRoche Diagnostics · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002905 | Access Thyroglobulin Reagents on the Access Analyzer | Beckman Coulter, Inc. | 2000 | — |
| +1 | K220972 | Access Thyroglobulin | Beckman Coulter, Inc. | 2023 | — |
| +2 | K241423 | Access Thyroglobulin | Beckman Coulter, Inc. | 2024 | — |
| +3 | K242981 | Atellica IM Thyroglobulin (Tg) | Siemens Healthcare Diagnostics, Inc. | 2025 | — |
| +2 | K240927 | Access Thyroglobulin | Beckman Coulter, Inc. | 2024 | — |
| +1 | K221890 | Elecsys Tg II | Roche Diagnostics | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
3 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 |
|---|---|---|---|---|
| Apr 30, 2019 | Class II | Z-2240-2020 | 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… |
| May 9, 2017 | Class II | Z-2636-2017 | Device Design | The Access immunoassays are susceptible to biotin interference. |
| Jul 28, 2015 | Class II | Z-2733-2015 | Under Investigation by firm | Beckman Coulter, Inc. is recalling Access Thyroglobulin reagent packs because some may exhibit greater than 10% imprecision at concentrations <10 ng/mL. |
| Oct 18, 2010 | Not classified | Z-2215-2011 | Other | The recall was initiated because In addition to Access Tg Sample Diluent, an additional diluent, Access Wash Buffer II, was added to Thyroglobulin instructions for use (IFU) for evaluation of samples having Tg levels above the reportable… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K220972 (Beckman Coulter, Inc., 2023) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MSW devicesMSW System, Test, Thyroglobulin: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K002905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002905: Access Thyroglobulin Reagents on the Access Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002905
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026