510(k) · Cleared
ClearedVitalab Iron Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clinical Data, Inc. · JIY Photometric Method, Iron (Non-Heme)
Cleared on May 21, 2004 after a 150-day review. The FDA summary names its predicate without a number.
- Decided
- May 21, 2004
- Review
- 150 days
- Class
- Class I
- Product code
- JIY
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (2)
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 |
|---|---|---|---|
| * | — | Beckman Iron Reagent Kit Named without a submission number | |
| * | — | Synchron Multi-Calibrator Named without a submission number |
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.
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 Vitalab Iron Reagent Kit, which contains both reagent and calibrator, is intended for use with the Vitalab Selectra E Analyzer as a system for the quantitative determination of total iron in serum and plasma. Iron results may be used for the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033983 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033983: Vitalab Iron Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033983
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026