510(k) · Cleared
ClearedQuantex Ferritin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · DBF Ferritin, Antigen, Antiserum, Control
Cleared on May 10, 2004 as substantially equivalent to K935847 (Abbott Laboratories, 1994) after a 35-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- May 10, 2004
- Review
- 35 days
- Class
- Class II
- Product code
- DBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K935847 (1994). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K052617Ferritin Lit Assay, Catalog NO. 7010; Ferritin Calibrator Set, Catalog NO. 7510…Good Biotech Corp. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935847 | Axsym Ferritin | Abbott Laboratories | 1994 | — |
| 0 (this device) | K040879 | Quantex Ferritin | Instrumentation Laboratory CO | 2004 | — |
| +1 | K052617 | Ferritin Lit Assay, Catalog NO. 7010; Ferritin Calibrator Set, Catalog NO.… | Good Biotech Corp. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 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 |
|---|---|---|---|
| * | K935847 | Axsym FerritinSummary page 1…(s): 866.5340 Ferritin Immunological Test System Class II DBF Ferritin, Antigen, Antiserum, Control Identification of predicate device(s): K935847 AxSYM Ferritin Description of the device/intended use(s): Quantex Ferritin is intended as a latex particle enhanced immuno… | 1994 |
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 |
|---|---|---|---|
| K052617 | Ferritin Lit Assay, Catalog NO. 7010; Ferritin Calibrator Set, Catalog NO. 7510… | 2006 | 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?
- Its one ancestor has no recall.
- Of its descendants, K052617 (Good Biotech Corp., 2006) has gone furthest, with 0 descendants of its own.
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 | — |
What is it indicated for?
Quantex Ferritin is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of ferritin in human serum or EDTA plasma on Clinical Chemistry Systems, and aids in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
The quantex Ferritin controls I/1l are intended for use in monitoring the quality control of results obtained with the quantex Ferritin reagents by turbidimetry.
The quantex Ferritin standard multipoint is intended for use in establishing the calibration curve for the quantex Ferritin reagents by turbidimetry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040879 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040879: Quantex Ferritin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040879
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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