510(k) · Cleared
Recalled · Class II · 2017Dimension Vista Ferritin Flex Reagent Cartridge (Ferr)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JIT Calibrator, Secondary
Cleared on Apr 30, 2007 as substantially equivalent to K963498 (Dade Chemistry Systems, Inc., 1997) and 1 other predicate after a 62-day review. Its family tree reaches back 2 generations to 1996. It has been recalled once.
- Decided
- Apr 30, 2007
- Review
- 62 days
- Class
- Class II
- Product code
- JIT
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K963493 (1996). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963493 | Ferritin Calibrator | Dade Chemistry Systems, Inc. | 1996 | — |
| −1 | K983548 | Ferritin Calibrator | Dade Behring, Inc. | 1998 | — |
| 0 (this device) | K070552 | Dimension Vista Ferritin Flex Reagent Cartridge (Ferr) | Dade Behring, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 JIT? 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 |
|---|---|---|---|
| * | K963498 | Ferr Flex Reagent CartridgeSummary page 1…ct Product Device number Class Code Ferritin (FERR) Flex® reagent Ferritin (FERR) Flex® K963498 II 866.5340 DRE cartridge for the Dimension reagent cartridge for the VistaTM system (K6440)… | 1997 |
| * | K983548 | Ferritin CalibratorSummary page 1…M system (K6440) Dimension® clinical chemistry system (RF440)_ Dimension VistaTM LOCI 4 Dimension FERR K983548 II 862.1150 JIT Calibrator Calibrator Device Description: The Dimension VistaTM FER… | 1998 |
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 |
|---|---|---|---|---|
| Mar 21, 2017 | Class II | Z-2609-2017 | Under Investigation by firm | The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 8.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K963498.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, 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 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The FERR method is an in vitro diagnostic device for the quantitative measurement of ferritin in human serum and plasma (lithium or sodium heparin, and EDTA) on the Dimension Vista® System. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
The Dimension Vista™ LOCI 4 Calibrator is an in vitro diagnostic device intended to be used to calibrate the ferritin (FERR) assay on the Dimension Vista™ system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070552 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070552: Dimension Vista Ferritin Flex Reagent Cartridge (Ferr).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070552
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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