510(k) · Cleared
Recalled · Class III · 2012Total Iron Binding Capacity (Ibct) Flex Reagent Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JMO Ferrozine (Colorimetric) Iron Binding Capacity
Cleared on Jan 28, 2000 as substantially equivalent to K864230 (E.I. Dupont DE Nemours & Co., Inc., 1986) after a 53-day review. Its family tree reaches back 1 generation to 1986. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 28, 2000
- Review
- 53 days
- Class
- Class I
- Product code
- JMO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K864230 (1986). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK864230 Dimension (TM) Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc. · 1986
- This deviceK994115 Total Iron Binding Capacity (Ibct) Flex Reagent CartridgeDade Behring, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK061020 Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino…Dade Behring, Inc. · 2006 · Recalled
- Descendant · cites it directly · 0 of its ownK052867 Vitros Chemistry Products Dtibc ReagentOrtho-Clinical Diagnostics, Inc. · 2005 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864230 | Dimension (TM) Clinical Chemistry System | E.I. Dupont DE Nemours & Co., Inc. | 1986 | — |
| 0 (this device) | K994115 | Total Iron Binding Capacity (Ibct) Flex Reagent Cartridge | Dade Behring, Inc. | 2000 | — |
| +1 | K061020 | Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase… | Dade Behring, Inc. | 2006 | 1 |
| +1 | K052867 | Vitros Chemistry Products Dtibc Reagent | Ortho-Clinical Diagnostics, Inc. | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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 JMO? 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 |
|---|---|---|---|
| * | K864230 | Dimension (TM) Clinical Chemistry SystemSummary page 1…ex® reagent cartridge FDA Classification Name: Iron Binding Capacity Test System Predicate Device: Dimension® Total Iron Binding Capacity (TIBC) Flex® reagent cartridge (K864230) Device Description: The IBCT method for the Dimension® clinical chemistry system is a fully automated assay in which serum or p… | 1986 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 20, 2012 | Class III | Z-0933-2013 | Process design | The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid. Siemens is conducting a voluntary corrective action for Dimension Total Iron Binding Capacity (IBCT) to modify the analytical… |
| Dec 16, 2009 | Not classified | Z-2385-2010 | Nonconforming Material/Component | Test produces falsely elevated IBCT results and Abnormal Reaction test report messages on heparinized plasma samples. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K061020 (Dade Behring, Inc., 2006) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JMO devicesJMO Ferrozine (Colorimetric) Iron Binding Capacity: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JMO
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · JMO
Too few JMO 510(k)s in any year since 2007 to give a median.
Recalls per year · JMO
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JMO
No MAUDE report names JMO since 2007.
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 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Total Iron Binding Capacity (IBCT) Flex® reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure total iron binding capacity in human serum and plasma. Measurements of total iron binding capacity are used in the diagnosis and treatment of iron deficiency anemia and chronic inflammatory disorders.
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/K994115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994115: Total Iron Binding Capacity (Ibct) Flex Reagent Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994115
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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