510(k) · Cleared
Recalled · Class II · 2012Advia Chemistry Ferritin (FRT) Method
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · DBF Ferritin, Antigen, Antiserum, Control
Cleared on Aug 17, 2011 as substantially equivalent to K993273 (Dade Behring, Inc., 1999) and 1 other predicate after a 154-day review. Its family tree reaches back 2 generations to 1995. It has been recalled 3 times.
- Decided
- Aug 17, 2011
- Review
- 154 days
- Class
- Class II
- Product code
- DBF
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 2 generations to K950707 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950707 | N Latex Ferritin | Behring Diagnostics, Inc. | 1995 | — |
| −1 | K993273 | N Latex Ferritin | Dade Behring, Inc. | 1999 | — |
| 0 (this device) | K110736 | Advia Chemistry Ferritin (FRT) Method | Siemens Healthcare Diagnostics, Inc. | 2011 | — |
Other ancestors 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? (2)
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 |
|---|---|---|---|
| * | K993273 | N Latex FerritinSummary page 1…Regulation Product number Class Code ADVIA® Chemistry N Latex Ferritin k993273 Class 11 866.5340 DBF Ferritin (FRT) reagent -Reagent ADVIA® Chemistry Randox Liquid k06… | 1999 |
| * | K061056 | Randox Liquid Protein CalibratorSummary page 1…ry N Latex Ferritin k993273 Class 11 866.5340 DBF Ferritin (FRT) reagent -Reagent ADVIA® Chemistry Randox Liquid k061056 Class 11 862.1150 JIX Liquid Specific Protein Calibrator… | 2006 |
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 |
|---|---|---|---|---|
| Oct 9, 2012 | Class II | Z-0128-2015 | Nonconforming Material/Component | Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system |
| Oct 9, 2012 | Class II | Z-0129-2015 | Nonconforming Material/Component | Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system |
| Oct 9, 2012 | Class II | Z-0130-2015 | Nonconforming Material/Component | Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 11.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All DBF devicesDBF Ferritin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 ADVIA® 1650 Chemistry Ferritin (FRT) Reagent: For in vitro diagnostic use in the quantitative determination of ferritin in human serum and plasma on the ADVIA® 165OtChemistry system. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia. The AD VIA® Chemistry Liquid Specific Protein Calibrators: For in vitro diagnostic use in the calibration of AD VIA®…
Read the full statement (108 words)
The ADVIA® 1650 Chemistry Ferritin (FRT) Reagent:
For in vitro diagnostic use in the quantitative determination of ferritin in human serum and plasma on the ADVIA® 165OtChemistry system. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
The AD VIA® Chemistry Liquid Specific Protein Calibrators: For in vitro diagnostic use in the calibration of AD VIA® Chemistry systems for the Alpha-Acid-Glycoprotein (AAG), Alpha- I-Antitrypsin (AAT), Anti-streptolysin-0_2 (ASO_2), Complement C3 (C3), Complement C4 (C4), Ferritin (ERT), Haptoglobin (HAPT), Immunoglobulin A_2 (IGA 2), Immunoglobulin G6_2 (lG_2), Immunoglobulin M_2 (IGM_2), Prealbumnin (PREALB), Rheumatoid Factor (RF), and Transferrin (TRF) methods.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K110736 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110736: Advia Chemistry Ferritin (FRT) Method.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110736
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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