510(k) Report

510(k) · Cleared

Cleared

Dimension Vista C1 in; Flex Reagent Cartridge, Cal, Con

K072965510(k) TraditionalCleared Dec 21, 200760-day reviewClass II21 CFR 866.5250

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

Dade Behring, Inc. · DBA Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control

Cleared on Dec 21, 2007 as substantially equivalent to K960257 (Behring Diagnostics, Inc., 1996) and 2 other predicates after a 60-day review. Its family tree reaches back 1 generation to 1996.

Decided
Dec 21, 2007
Review
60 days
Class
Class II
Product code
DBA
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K962410 (1996). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 2 other ancestorsK962410 · N Protein Standard PY · Behring Diagnostics, Inc. · 19961996199820002002200420062008
Other ancestors, by generation 1 generation back: 2 other ancestors K962410 · N Protein Standard PY · Behring Diagnostics, Inc. · 19960
  1. Root · 1 generation backK962410 N Protein Standard PYBehring Diagnostics, Inc. · 1996
  2. This deviceK072965 Dimension Vista C1 in; Flex Reagent Cartridge, Cal, ConDade Behring, Inc. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K962410N Protein Standard PYBehring Diagnostics, Inc.1996—
0 (this device)K072965Dimension Vista C1 in; Flex Reagent Cartridge, Cal, ConDade Behring, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
FIG. 1 — Lineage of K072965, 1996–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 DBA? 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
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K960257N Antiserum to C1 Inhibitor
Summary page 1
…Immunology (82) and Clinical Chemistry (75) 3. Identification of the Legally Marketed Devices: Dade Behring NAntisera to Human C1 Inhibitor- K960257 Dade Behring N Protein Standard PY - K962410 Dade Behring N/T Protein Control PY - K962407 Da…
Behring Diagnostics, Inc.1996—
*K962410N Protein Standard PY
Summary page 1
…3. Identification of the Legally Marketed Devices: Dade Behring NAntisera to Human C1 Inhibitor- K960257 Dade Behring N Protein Standard PY - K962410 Dade Behring N/T Protein Control PY - K962407 Dade Behring Inc. Dimension Vista® CIIN 510(k) Notificati…
Behring Diagnostics, Inc.1996—
*K962407N/T Protein Control PY
Summary page 1
…s: Dade Behring NAntisera to Human C1 Inhibitor- K960257 Dade Behring N Protein Standard PY - K962410 Dade Behring N/T Protein Control PY - K962407 Dade Behring Inc. Dimension Vista® CIIN 510(k) Notification 4. Device Descriptions: Dimension V…
Behring Diagnostics, Inc.1996—

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?

  • None of the 3 ancestors has a recall.

How does its category compare?

All DBA devices

DBA Complement C1 Inhibitor (Inactivator), 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 · DBA

1in 2014

2007: 12013: 12014: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DBA

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

Recalls per year · DBA

No recall names DBA since 2007.

Adverse event reports per year · DBA

No MAUDE report names DBA since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20090—00
20100—00
20110—00
20120—00
20131—00
20141—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The CGIN method is an in vitro diagnostic test for the quantitative measurement of C1 inhibitor in human serum and plasma on the Dimension Vista® System. Measurements of C1 Inhibitor aid in the diagnosis of hereditary angioneurotic edema (increase blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer). The C1 INCAL is an in vitro diagnostic product for the calibration of the C1…

Read the full statement (114 words)

The CGIN method is an in vitro diagnostic test for the quantitative measurement of C1 inhibitor in human serum and plasma on the Dimension Vista® System. Measurements of C1 Inhibitor aid in the diagnosis of hereditary angioneurotic edema (increase blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).

The C1 INCAL is an in vitro diagnostic product for the calibration of the C1 Inhibitor (Cl IN) method on the Dimension Vista® System.

C1 Inhibitor Control is an assayed, mid level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of C1 Inhibitor (Cl IN).

Indications for use as stated in the FDA summary.

More from Dade Behring, Inc.

347 FDA decisions under this applicant name. See the company

  • K093848PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc. · 2010
  • K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and…Dade Behring, Inc. · 2008
  • K081249Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension…Dade Behring, Inc. · 2008
  • K071603Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)Dade Behring, Inc. · 2008
  • K071597Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci 5 Calibrator…Dade Behring, Inc. · 2008

Recent decisions in DBA

The DBA category page

  • K141100Optilite C1 Inactivator KitThe Binding Site Group, Ltd. · 2014
  • K122304Human C1 Inactivator Kit for Use on SpaplusThe Binding Site Group, Ltd. · 2013
  • K011780K-Assay C1-InaKamiya Biomedical Co. · 2001
  • K003747C1-Inhibitor Microtiter Assay DeviceBaxter Healthcare Corp · 2001
  • K965024N-Assay Tia C1-Inactivator Test KitCrestat Diagnostics, Inc. · 1997

https://510kreport.com/device/K072965 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072965: Dimension Vista C1 in; Flex Reagent Cartridge, Cal, Con.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072965

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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