510(k) · Cleared
ClearedK-Assay (R) Ferritin Reagent, K-Assay (R) Ferritin Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kamiya Biomedical Company · DBF Ferritin, Antigen, Antiserum, Control
Cleared on May 24, 2012 as substantially equivalent to K050944 (Kamiya Biomedical Co., 2005) after a 30-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- May 24, 2012
- Review
- 30 days
- Class
- Class II
- Product code
- DBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K050944 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backK050944 K-Assay Ferritin (2) & Ferritin Calibrator SetKamiya Biomedical Co. · 2005
- This deviceK121232 K-Assay (R) Ferritin Reagent, K-Assay (R) Ferritin CalibratorKamiya Biomedical Company · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K050944 | K-Assay Ferritin (2) & Ferritin Calibrator Set | Kamiya Biomedical Co. | 2005 | — |
| 0 (this device) | K121232 | K-Assay (R) Ferritin Reagent, K-Assay (R) Ferritin Calibrator | Kamiya Biomedical Company | 2012 | — |
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 DBF? 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 DBF device
- #1 K193650 LIAISON Ferritinscore 2.0 · 1 generation · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K050944 | K-Assay Ferritin (2) & Ferritin Calibrator SetSummary page 2…reservative. J. Substantial Equivalence Information: 1. Predicate device name(s) and predicate K number(s): K-ASSAY® Ferritin (2) and Ferritin Calibrator set (k050944) 2. Comparison with predicate Ferritin Reagent… | 2005 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K050944.
How does its category compare?
All DBF devicesDBF Ferritin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DBF
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · DBF
Too few DBF 510(k)s in any year since 2007 to give a median.
Recalls per year · DBF
3in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DBF
1in 2025
MAUDE reports naming product code DBF, 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 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 3 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The K-ASSAY 0 Ferritin (2nd Gen.) assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and plasma by immunoturbidimetric assay on the Beckman AU680. Measurements of ferritin aid in the diagnosis of diseases affecting iron overload and iron deficiency anemia. FOR IN VITRO DIAGNOSTIC USE.
The K-ASSAY ® Ferritin Calibrator (2nd Gen.) is an in vitro diagnostic reagent for calibration of the K-ASSAY® Ferritin (2nd Gen.) assay. FOR IN VITRO DIAGNOSTIC USE.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121232: K-Assay (R) Ferritin Reagent, K-Assay (R) Ferritin Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121232
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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