510(k) · Cleared
ClearedAccess STFR, Access STFR Calibrators, and Access STFR QC with Models, A32493, A32494, and A32495
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 Aug 11, 2008 as substantially equivalent to K970718 (R&D Systems, Inc., 1997) after a 158-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Aug 11, 2008
- Review
- 158 days
- Class
- Class II
- Product code
- DDG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K926221 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK926221 Access Ferritin AssayBio-Rad Laboratories, Inc. · 1993 · Recalled
- 1 generation backK970718 Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa)R&D Systems, Inc. · 1997 · Recalled
- This deviceK080634 Access STFR, Access STFR Calibrators, and Access STFR QC with…Beckman Coulter, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK240987 Access sTfRBeckman Coulter, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240987Access sTfRBeckman Coulter, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K926221 | Access Ferritin Assay | Bio-Rad Laboratories, Inc. | 1993 | 1 |
| −1 | K970718 | Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa) | R&D Systems, Inc. | 1997 | 3 |
| 0 (this device) | K080634 | Access STFR, Access STFR Calibrators, and Access STFR QC with Models, A32493… | Beckman Coulter, Inc. | 2008 | — |
| +1 | K240987 | Access sTfR | Beckman Coulter, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 DDG? 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 DDG device
- #1 K240987 Access sTfRscore 8.2 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K970718 | Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa)Summary page 1…ion Name: Transferrin Immunological Test Predicate Device Quantikine® IVD® sTfR ELISA R & 0 Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413 510(k) Number: K970718 Device Description The Access sTfR reagent, calibrators, controls, and the Access lmmunoassay Analyzers (Access, Access 2, Sync… | 1997 |
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 |
|---|---|---|---|
| K240987 | Access sTfR | 2024 | 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 15 years and passes through 3 companies; a new generation was cleared every 11.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K240987 (Beckman Coulter, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K970718.
How does its category compare?
All DDG devicesDDG Transferrin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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…
Read the full statement (147 words)
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.
The Access sTfR Calibrators are intended to calibrate the Access sTfR assay for the quantitative determination of soluble transferrin receptor levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
The Access sTfR QC is intended for monitoring system performance of the Access sTfR assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080634 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080634: Access STFR, Access STFR Calibrators, and Access STFR QC with Models, A32493, A32494, and A32495.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080634
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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