510(k) · Cleared
ClearedVitros Chemistry Products Tibc Kit, Model 886 7541; Calibrator Kit 4, Model 120 4668
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 Jun 15, 2006 as substantially equivalent to K931493 (Eastman Kodak Company, 1993) after a 21-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Jun 15, 2006
- Review
- 21 days
- Class
- Class I
- Product code
- JMO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931493 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK931493 Kodak Ektachem Total Iron-Binding Capacity KitEastman Kodak Company · 1993
- This deviceK061464 Vitros Chemistry Products Tibc Kit, Model 886 7541; Calibrator Kit…Ortho-Clinical Diagnostics, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931493 | Kodak Ektachem Total Iron-Binding Capacity Kit | Eastman Kodak Company | 1993 | — |
| 0 (this device) | K061464 | Vitros Chemistry Products Tibc Kit, Model 886 7541; Calibrator Kit 4, Model… | Ortho-Clinical Diagnostics, Inc. | 2006 | — |
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 |
|---|---|---|---|
| * | K931493 | Kodak Ektachem Total Iron-Binding Capacity KitSummary page 1…tially equivalent to the device VITROS TJBC assay (original). This assay was originally cleared under the KODAK EKTACHEM product branding (K93 1493). Continued on next page SPECIAL 5 10(K) SUBMISS… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
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.
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 TIBC Kit with VITROS Chemistry Products Fe Slides quantitatively measures total iron-binding capacity (TIBC) in serum. The iron binding capacity is useful in the differential diagnosis of anemia, iron deficiency anemia, thalassemia, sideroblastic anemia, and iron poisoning.
VITROS Chemistry Products Calibrator Kit 4 is used to calibrate VITROS Chemistry Systems for the quantitative measurement of ALB, BuBc, Fe, TBIL, TIBC, and TP.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061464 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061464: Vitros Chemistry Products Tibc Kit, Model 886 7541; Calibrator Kit 4, Model 120 4668.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061464
Report an extraction error
Are you the manufacturer?
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