510(k) · Cleared
Recalled · Class III · 2016Vitros Chemistry Products Dtibc Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · JMO Ferrozine (Colorimetric) Iron Binding Capacity
Cleared on Dec 23, 2005 as substantially equivalent to K994115 (Dade Behring, Inc., 2000) and 2 other predicates after a 73-day review. Its family tree reaches back 3 generations to 1999. It has been recalled once.
- Decided
- Dec 23, 2005
- Review
- 73 days
- Class
- Class I
- Product code
- JMO
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K983849 (1999). 8 ancestors in all, the oldest K863840 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backK983849 Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex…Dade Behring, Inc. · 1999
- 2 generations backK032798 Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge…Dade Behring, Inc. · 2003
- 1 generation backK042006 Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2004 · Recalled
- This deviceK052867 Vitros Chemistry Products Dtibc ReagentOrtho-Clinical Diagnostics, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K983849 | Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex Reagent… | Dade Behring, Inc. | 1999 | — |
| −2 | K032798 | Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge (DF48A)… | Dade Behring, Inc. | 2003 | — |
| −1 | K042006 | Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2004 | 3 |
| 0 (this device) | K052867 | Vitros Chemistry Products Dtibc Reagent | Ortho-Clinical Diagnostics, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1990 | 1 | 0 |
| 2000 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K994115 | Total Iron Binding Capacity (Ibct) Flex Reagent CartridgeSummary page 3…Products Calibrator Kit 29 are substantially equivalent to the Dade Behring devices Total Iron Binding Capacity (IBCT) Flex reagent cartridge (K994115) on the Dimension® clinical chemistry systems. (K994115) and Dade Behring… | 2000 |
| * | K994114 | Dimension Total Iron Binding Capacity (Ibct) CalibratorSummary page 3…ent cartridge (K994115) on the Dimension® clinical chemistry systems. (K994115) and Dade Behring IBCT Calibrator (K994114) (predicate devices) which were cleared by the FDA for IVD use. The relat… | 2000 |
| * | K042006 | Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products Calibrator Kit 25…Summary page 4…substantially equivalent to the VITROS Chemistry Products Performance devices Verifiers I & II (predicate device) which was cleared by the FDA (K042006) (continued) for IVD use. In addition to correlation studies, bench testing was perfo… | 2004 |
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 |
|---|---|---|---|---|
| May 24, 2016 | Class III | Z-2119-2016 | Nonconforming Material/Component | Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Ortho's investigation confirmed that incorrect calibration mathematics were assigned to the Calibrator… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K994115.
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?
For in vitro diagnostic use only. VITROS Chemistry Products dTIBC Reagent is used to quantitatively measure total iron-binding capacity (TIBC) in human serum. The iron binding capacity is useful in the differential diagnosis of anemia, iron deficiency anemia, thalassemia, sideroblastic anemia, and iron poisoning. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 is used to calibrate VITROS 5,1 FS Chemistry Systems for the…
Read the full statement (104 words)
For in vitro diagnostic use only. VITROS Chemistry Products dTIBC Reagent is used to quantitatively measure total iron-binding capacity (TIBC) in human serum. The iron binding capacity is useful in the differential diagnosis of anemia, iron deficiency anemia, thalassemia, sideroblastic anemia, and iron poisoning.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent.
For in vitro diagnostic use only. VITROS Chemistry Products Performance Verifiers are assayed controls intended for use in monitoring performance on VITROS Chemistry Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052867 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052867: Vitros Chemistry Products Dtibc Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052867
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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