510(k) · Cleared

Cleared

Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control Medium, and Protein 1 Control High

K063425510(k) TraditionalCleared Feb 15, 200794-day reviewClass II21 CFR 866.5510

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

Dade Behring, Inc. · DGC Ige, Antigen, Antiserum, Control

Cleared on Feb 15, 2007 as substantially equivalent to K991787 (Dade Behring, Inc., 1999) and 2 other predicates after a 94-day review. Its family tree reaches back 2 generations to 1989.

Decided: Feb 15, 2007
Review: 94 days
Class: Class II
Product code: DGC
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K890530 (1989). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK890530 N Latex Ige Kit (Immunoglobulin E Reagents)Behring Diagnostics, Inc. · 1989
1 generation backK991787 N Latex Ige Mono ReagentDade Behring, Inc. · 1999
This deviceK063425 Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator…Dade Behring, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K890530	N Latex Ige Kit (Immunoglobulin E Reagents)	Behring Diagnostics, Inc.	1989	—
−1	K991787	N Latex Ige Mono Reagent	Dade Behring, Inc.	1999	—
0 (this device)	K063425	Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1…	Dade Behring, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	2	0
2001	2	0

FIG. 1 — Lineage of K063425, 1989–2007Source: 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 DGC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DGC device

#1 K231151 Kenota 1 Total IgE; Kenota 1 (instrument)score 8.0 · 3 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

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
*	K991787	N Latex Ige Mono Reagent Summary page 1 …Panel: Immunology (82) and Clinical Chemistry (75) 3. Identification of the Legally Marketed Device: Dade Behring N Latex IgE mono- K991787 Dade Behring N Protein Standard SL - K012470 Dade Behring NIT Protein Control SL - K012468…	Dade Behring, Inc.	1999	—
*	K012470	Modification to N Protein Standard SL Summary page 1 …inical Chemistry (75) 3. Identification of the Legally Marketed Device: Dade Behring N Latex IgE mono- K991787 Dade Behring N Protein Standard SL - K012470 Dade Behring NIT Protein Control SL - K012468…	Dade Behring, Inc.	2001	1
*	K012468	Modification to N/T Protein Control SL Summary page 1 …egally Marketed Device: Dade Behring N Latex IgE mono- K991787 Dade Behring N Protein Standard SL - K012470 Dade Behring NIT Protein Control SL - K012468 000104t Dade Behring Inc. D…	Dade Behring, Inc.	2001	—

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?

The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 10.3 years on median.
1 of the 6 ancestors has a recall of any class.

How does its category compare?

All DGC devices

DGC Ige, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · DGC

1in 2024

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DGC

Too few DGC 510(k)s in any year since 2007 to give a median.

Recalls per year · DGC

1in 2016

2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · DGC

2in 2021

2007high 13 (2011) · low 0 (2007)2025

MAUDE reports naming product code DGC, 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	1	—	0	0
2008	0	—	0	2
2009	0	—	1	5
2010	0	—	0	12
2011	0	—	0	13
2012	0	—	0	0
2013	0	—	0	1
2014	1	—	0	1
2015	0	—	0	2
2016	1	—	1	2
2017	0	—	0	0
2018	0	—	0	0
2019	0	—	0	0
2020	1	—	0	0
2021	0	—	0	2
2022	1	—	0	0
2023	1	—	0	0
2024	1	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The IGE method is an in vitro diagnostic test for the quantitative determination of Immunoglobulin E in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of IGE aid in the diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings. PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin E…

Read the full statement (135 words)

The IGE method is an in vitro diagnostic test for the quantitative determination of

Immunoglobulin E in human serum, heparinized plasma or EDTA plasma on the

Dimension Vista® System. Measurements of IGE aid in the diagnosis of IgE

mediated allergic disorders in conjunction with other clinical findings.

PROT1 CAL is an in vitro diagnostic product for the calibration of the C3

Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA),

Immunoglobulin E (IGE), Immunoglobulin G (IGG), Immunoglobulin M (IGM),

and Prealbumin (PREALB) methods on the Dimension Vista System.

PROT1 CON L, M and H are assayed intralaboratory quality controls for

assessment of precision and analytical bias in the determination of C3

Complement (C3), C4 Complement (C4), immunoglobulin A (IGA),

immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM),

and prealbumin (PREALB) on the Dimension Vista® System.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063425 · printed Nov 5, 2026

Cite this page

510(k) Report. “K063425: Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control Medium, and Protein 1 Control High.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063425

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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