510(k) · Cleared
ClearedAccess sTfR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · DDG Transferrin, Antigen, Antiserum, Control
Cleared on Jul 3, 2024 as substantially equivalent to K080634 (Beckman Coulter, Inc., 2008) after an 84-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Jul 3, 2024
- Review
- 84 days
- Class
- Class II
- Product code
- DDG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K926221 (1993). No later device cites it as a predicate yet.
- Root · 3 generations backK926221 Access Ferritin AssayBio-Rad Laboratories, Inc. · 1993 · Recalled
- 2 generations backK970718 Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa)R&D Systems, Inc. · 1997 · Recalled
- 1 generation backK080634 Access STFR, Access STFR Calibrators, and Access STFR QC with…Beckman Coulter, Inc. · 2008
- This deviceK240987 Access sTfRBeckman Coulter, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K926221 | Access Ferritin Assay | Bio-Rad Laboratories, Inc. | 1993 | 1 |
| −2 | K970718 | Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa) | R&D Systems, Inc. | 1997 | 3 |
| −1 | K080634 | Access STFR, Access STFR Calibrators, and Access STFR QC with Models, A32493… | Beckman Coulter, Inc. | 2008 | — |
| 0 (this device) | K240987 | Access sTfR | Beckman Coulter, Inc. | 2024 | — |
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 DDG? 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080634 | Access STFR, Access STFR Calibrators, and Access STFR QC with Models, A32493, A32494…Summary page 4…alyzer Classification Name: Transferrin immunological test system Classification Regulation: [21 CFR 866.5880] Predicate Device Device Name: Access sTfR 510(k) Numbers: k080634 Device Description Access sTfR: The sTfR assay reagent pack consists of two specific reagents: (R1a) paramagnetic particles coat… | 2008 |
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 31 years and passes through 3 companies; a new generation was cleared every 11.2 years on median.
- 2 of the 3 ancestors have a recall of any class.
How does its category compare?
All DDG devicesDDG Transferrin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · DDG
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DDG
114in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DDG
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DDG
1in 2015
MAUDE reports naming product code DDG, 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 | 4 | 114 | 0 | 0 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 2 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Access sTfR assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of soluble transferrin receptor (sTfR) levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of Iron Deficiency Anemia (IDA), and for the differential diagnosis of IDA and Anemia of Chronic Disease (ACD).
This assay may also be used in conjunction with an Access Ferritin measurement to provide a calculated sTfR/log ferritin index. This index is intended as an aid in the diagnosis of IDA, and for the differential diagnosis of IDA and ACD.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240987 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240987: Access sTfR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240987
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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