510(k) · Cleared
Recalled · Class III · 2016Dimension Iron Flex Reagent Cartridge (Iron-DF85)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JIY Photometric Method, Iron (Non-Heme)
Cleared on Mar 8, 2006 as substantially equivalent to K944093 (E.I. Dupont DE Nemours & Co., Inc., 1994) after a 35-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Mar 8, 2006
- Review
- 35 days
- Class
- Class I
- Product code
- JIY
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944093 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK944093 Dimension (R) XL Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc. · 1994
- This deviceK060264 Dimension Iron Flex Reagent Cartridge (Iron-DF85)Dade Behring, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK061793 Dimension Vista Iron Flex Reagent Cartridge and CalibratorDade Behring, Inc. · 2006 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K061793Dimension Vista Iron Flex Reagent Cartridge and CalibratorDade Behring, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944093 | Dimension (R) XL Clinical Chemistry System | E.I. Dupont DE Nemours & Co., Inc. | 1994 | — |
| 0 (this device) | K060264 | Dimension Iron Flex Reagent Cartridge (Iron-DF85) | Dade Behring, Inc. | 2006 | — |
| +1 | K061793 | Dimension Vista Iron Flex Reagent Cartridge and Calibrator | Dade Behring, Inc. | 2006 | 1 |
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 JIY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K944093 | Dimension (R) XL Clinical Chemistry SystemSummary page 2…of iron in serum and plasma. 1. Substantial Equivalence Information: 1. Predicate Device: Dimension® IRN Iron Flex® reagent cartridge (DF49A) 2. Predicate K Number(s): K944093 3. Comparison with Predicate: Similarities Intended Use Quantitative determina… | 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 |
|---|---|---|---|
| K061793 | Dimension Vista Iron Flex Reagent Cartridge and Calibrator | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 25, 2016 | Class III | Z-0401-2017 | Error in labeling | Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instructions for Use (IFU). |
| Aug 25, 2016 | Class III | Z-0402-2017 | Error in labeling | Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instructions for Use (IFU). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JIY devicesJIY Photometric Method, Iron (Non-Heme): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIY
FDA has decided no JIY device since 2007.
Median 510(k) review, days · JIY
Too few JIY 510(k)s in any year since 2007 to give a median.
Recalls per year · JIY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIY
7in 2025
MAUDE reports naming product code JIY, 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 | — | 1 | 0 |
| 2009 | 0 | — | 8 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 15 |
| 2013 | 0 | — | 1 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 3 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 2 | 6 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 1 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IRON method for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure iron in human serum and plasma. Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060264: Dimension Iron Flex Reagent Cartridge (Iron-DF85).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060264
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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