510(k) · Cleared
ClearedTIBC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · JMO Ferrozine (Colorimetric) Iron Binding Capacity
Cleared on May 20, 1998 as substantially equivalent to K872494 (Boehringer Mannheim Corp., 1987) after a 42-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- May 20, 1998
- Review
- 42 days
- Class
- Class I
- Product code
- JMO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K872494 (1987). No later device cites it as a predicate yet.
- Root · 1 generation backK872494 Hitachi 717 Chemistry AnalyzerBoehringer Mannheim Corp. · 1987
- This deviceK981279 TIBCAbbott Laboratories · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872494 | Hitachi 717 Chemistry Analyzer | Boehringer Mannheim Corp. | 1987 | — |
| 0 (this device) | K981279 | TIBC | Abbott Laboratories | 1998 | — |
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 |
|---|---|---|---|
| * | K872494 | Hitachi 717 Chemistry AnalyzerSummary page 2…L Iwp 00006010 Substantial Equivalence: The TIBC assay is substantially equivalent to the Boehringer Mannheim® TIBC assay on the Hitachi® 717 Analyzer (K872494). Both assays yield similar Performance Characteristics. Similarities: + Both assays are in vitro clinical chemistry methods.… | 1987 |
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.
- 4 other devices also cite its predicate K872494.
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 (TIBC) assay uses TIBC sample pretreatment in conjunction with the Iron assay for the quantitation of the total iron binding capacity of human serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.
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/K981279 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981279: TIBC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981279
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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