510(k) · Cleared

Recalled · Class II · 2012

Dimension Vista Iron Flex Reagent Cartridge and Calibrator

K061793510(k) SpecialCleared Aug 7, 200642-day reviewClass I21 CFR 862.1410Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dade Behring, Inc. · JIY Photometric Method, Iron (Non-Heme)

Cleared on Aug 7, 2006 as substantially equivalent to K060264 (Dade Behring, Inc., 2006) and 1 other predicate after a 42-day review. Its family tree reaches back 2 generations to 1994. It has been recalled once.

Decided: Aug 7, 2006
Review: 42 days
Class: Class I
Product code: JIY
Recalls: 1
Predicates: 2

Its longest line of descent runs back 2 generations to K944093 (1994). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK944093 Dimension (R) XL Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc. · 1994
1 generation backK060264 Dimension Iron Flex Reagent Cartridge (Iron-DF85)Dade Behring, Inc. · 2006 · Recalled
This deviceK061793 Dimension Vista Iron Flex Reagent Cartridge and CalibratorDade Behring, Inc. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K944093	Dimension (R) XL Clinical Chemistry System	E.I. Dupont DE Nemours & Co., Inc.	1994	—
−1	K060264	Dimension Iron Flex Reagent Cartridge (Iron-DF85)	Dade Behring, Inc.	2006	2
0 (this device)	K061793	Dimension Vista Iron Flex Reagent Cartridge and Calibrator	Dade Behring, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K061793, 1994–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K060264	Dimension Iron Flex Reagent Cartridge (Iron-DF85) Summary page 2 …f iron in serum and plasma. I. Substantial Equivalence Information: 1. Predicate Device: Dimension® Iron Flex® reagent cartridge (IRON- DF85) 2. Predicate K Number(s): K060264 3. Comparison with Predicate: Similarities Intended Use Quantit…	Dade Behring, Inc.	2006	2
*	K060266	Dimension Iron Calibrator Summary page 5 …1.0 mL each, of the Calibrator A (1075 ug/dL). * Substantial Equivalence Information: 1. Predicate Device: Dimension® Iron Calibrator (DC85) 2. Predicate K Number(s): K060266 3. Comparison with Predicate: Similarities Intended Use To calibrate the iron meth…	Dade Behring, Inc.	2006	1

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
Oct 8, 2012	Class II	Z-0452-2013	Material/Component Contamination	Siemens Healthcare Diagnostics has confirmed the potential for falsely elevated results with IRON Flex(R) reagent cartridges when tests are processed from a well set contaminated with iron from environmental sources. All lots of IRON…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 11.3 years on median.
2 of the 3 ancestors have a recall of any class.

How does its category compare?

All JIY devices

JIY 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

2007high 8 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JIY

7in 2025

2007high 15 (2012) · low 0 (2007)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	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	1	0
2009	—	8	0
2010	—	0	0
2011	—	0	0
2012	—	1	15
2013	—	1	2
2014	—	0	0
2015	—	0	0
2016	—	3	2
2017	—	0	1
2018	—	0	0
2019	—	0	0
2020	—	0	3
2021	—	0	2
2022	—	0	3
2023	—	2	6
2024	—	0	8
2025	—	1	7
2026	—	0	—

What is it indicated for?

The iron method for the Dimension Vista TM system is an in vitro diagnostic test intended to quantitatively measure iron in human serum and plasma. Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.

The IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the IRON method for the Dimension Vista System.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061793 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061793: Dimension Vista Iron Flex Reagent Cartridge and Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061793

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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