510(k) · Cleared
Recalled · Class II · 2018Tandem (R)-M Ferritin Immunoenzymetric Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hybritech, Inc. · DBF Ferritin, Antigen, Antiserum, Control
Cleared on Oct 8, 1986 after a 40-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled once.
- Decided
- Oct 8, 1986
- Review
- 40 days
- Class
- Class II
- Product code
- DBF
- Recalls
- 1
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2018 | Class II | Z-2096-2018 | Device Design | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All DBF devicesDBF Ferritin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K863345 · printed Nov 4, 2026
Cite this page
510(k) Report. “K863345: Tandem (R)-M Ferritin Immunoenzymetric Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K863345
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026