510(k) · Cleared

Cleared

Dimension Vista TRF Flex Reagent Cartridge, Protein 1 Calibrator Protein 1 Control L,Control M, Control H

K063322510(k) TraditionalCleared Jan 24, 200782-day reviewClass II21 CFR 866.5880

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

Dade Behring, Inc. · DDG Transferrin, Antigen, Antiserum, Control

Cleared on Jan 24, 2007 as substantially equivalent to K053075 (Dade Behring, Inc., 2006) and 2 other predicates after an 82-day review. Its family tree reaches back 3 generations to 1993.

Decided: Jan 24, 2007
Review: 82 days
Class: Class II
Product code: DDG
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K926272 (1993). 7 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK926272 Beckman Transferrin KitBeckman Instruments, Inc. · 1993
2 generations backK972840 N Antiserum to Human TransferrinBehring Diagnostics, Inc. · 1997
1 generation backK053075 N Antisera to Human TransferrinDade Behring, Inc. · 2006
This deviceK063322 Dimension Vista TRF 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
−3	K926272	Beckman Transferrin Kit	Beckman Instruments, Inc.	1993	—
−2	K972840	N Antiserum to Human Transferrin	Behring Diagnostics, Inc.	1997	—
−1	K053075	N Antisera to Human Transferrin	Dade Behring, Inc.	2006	—
0 (this device)	K063322	Dimension Vista TRF 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 K063322, 1993–2007Source: 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 DDG? 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 DDG device

#1 K240987 Access sTfRscore 8.2 · 3 generations · no Class I recall

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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
*	K053075	N Antisera to Human Transferrin Summary page 1 …Immunology (82) and Clinical Chemistry (75) 3. Identification of the Legally Marketed Device: Dade Behring NAntisera to Human Transferrin- K053075 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468 L6NFIEWTIAL…	Dade Behring, Inc.	2006	—
*	K012470	Modification to N Protein Standard SL Summary page 1 …3. Identification of the Legally Marketed Device: Dade Behring NAntisera to Human Transferrin- K053075 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468 L6NFIEWTIAL…	Dade Behring, Inc.	2001	1
*	K012468	Modification to N/T Protein Control SL Summary page 1 …ce: Dade Behring NAntisera to Human Transferrin- K053075 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468 L6NFIEWTIAL Ujw 4. Device D…	Dade Behring, Inc.	2001	—

Also cleared against K053075: 2 other devices →

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 14 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
1 of the 7 ancestors has a recall of any class.
2 other devices also cite its predicate K053075.

How does its category compare?

All DDG devices

DDG Transferrin, 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 · DDG

1in 2024

2007high 4 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DDG

114in 2007

2007high 114 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DDG

2in 2019

2007high 2 (2019) · low 0 (2007)2026

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

Adverse event reports per year · DDG

1in 2015

2007high 1 (2015) · low 0 (2007)2025

MAUDE reports naming product code DDG, 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	4	114	0	0
2008	2	—	1	0
2009	0	—	0	0
2010	0	—	0	0
2011	0	—	0	0
2012	0	—	0	0
2013	1	—	0	0
2014	0	—	0	0
2015	0	—	0	1
2016	0	—	0	0
2017	0	—	0	0
2018	1	—	0	0
2019	0	—	2	0
2020	1	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	1	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The TRF method is an in vitro diagnostic test for the quantitative determination of transferrin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of transferrin aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia. PROTI CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G…

Read the full statement (130 words)

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

transferrin in human serum, heparinized plasma or EDTA plasma on the

Dimension Vista® System. Measurements of transferrin aid in the diagnosis of

malnutrition, acute inflammation, infection, and iron deficiency anemia.

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

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

Immunoglobulin G (IGG), Immunoglobulin M (IGM), Prealbumin (PREALB) and

Transferrin (TRF) methods on the Dimension Vista® System.

PROTI 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 G (IGG), immunoglobulin M (IGM), prealbumin (PREALB) and

transferrin (TRF) on the Dimension Vista® System.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063322 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063322: Dimension Vista TRF Flex Reagent Cartridge, Protein 1 Calibrator Protein 1 Control L,Control M, Control H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063322

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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