510(k) Report

510(k) · Cleared

Cleared

Dimension Vista A1AT Flex Reagent Cartridge and Protein 1 Calibrator and Control Medium and High

K063610510(k) TraditionalCleared Jan 11, 200738-day reviewClass II21 CFR 866.5130

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

Dade Behring, Inc. · DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control

Cleared on Jan 11, 2007 as substantially equivalent to K053072 (Dade Behring, Inc., 2006) and 2 other predicates after a 38-day review. Its family tree reaches back 2 generations to 2000.

Decided
Jan 11, 2007
Review
38 days
Class
Class II
Product code
DEM
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K002852 (2000). 6 ancestors in all, the oldest K860894 (1986). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1986: 1 other ancestorK002852 · N/T Protein Control SL · Dade Behring, Inc. · 2000K012468 · Modification to N/T Protein Control SL · Dade Behring, Inc. · 200119851990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors K012468 · Modification to N/T Protein Control SL · Dade Behring, Inc. · 2001K002852 · N/T Protein Control SL · Dade Behring, Inc. · 20000
  1. Root · 2 generations backK002852 N/T Protein Control SLDade Behring, Inc. · 2000
  2. 1 generation backK012468 Modification to N/T Protein Control SLDade Behring, Inc. · 2001
  3. This deviceK063610 Dimension Vista A1AT Flex Reagent Cartridge and Protein 1 Calibrator…Dade Behring, Inc. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K002852N/T Protein Control SLDade Behring, Inc.2000—
−1K012468Modification to N/T Protein Control SLDade Behring, Inc.2001—
0 (this device)K063610Dimension Vista A1AT Flex Reagent Cartridge and Protein 1 Calibrator and…Dade Behring, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
200010
200110
200610
FIG. 1 — Lineage of K063610, 2000–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 DEM? 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? (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
*K053072N Antisera to Human ALPHA1-Antitrypsin
Summary page 1
…Immunology (82) and Clinical Chemistry (75) 3. Identification of the Legally Marketed Devices: Dade Behring NAntisera to Human al-Antitrypsin- K053072 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468…
Dade Behring, Inc.2006—
*K012470Modification to N Protein Standard SL
Summary page 1
…. Identification of the Legally Marketed Devices: Dade Behring NAntisera to Human al-Antitrypsin- K053072 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468 j[t. AL 4. Device Descriptio…
Dade Behring, Inc.20011
*K012468Modification to N/T Protein Control SL
Summary page 1
…Dade Behring NAntisera to Human al-Antitrypsin- K053072 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468 j[t. AL 4. Device Descriptions: Dimension Vista'" AlAT Flex® reagent cartridge…
Dade Behring, Inc.2001—

Also cleared against K053072: 1 other device →

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 7 years and passes through 1 company; a new generation was cleared every 5.4 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • 1 other device also cites its predicate K053072.

How does its category compare?

All DEM devices

DEM Alpha-1-Antitrypsin, 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 · DEM

1in 2013

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

2026 to Oct 25, outlined.

Median 510(k) review, days · DEM

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

Recalls per year · DEM

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

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

Adverse event reports per year · DEM

1in 2024

2011: 12012: 12019: 12024: 1
2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code DEM, not matched to any one device; reports are not rates.

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—01
20120—01
20131—00
20140—00
20150—00
20160—00
20170—10
20180—00
20190—01
20200—00
20210—00
20220—00
20230—00
20240—01
20250—00
20260—0—

What is it indicated for?

The A1AT method is an in vitro diagnostic test for the quantitative determination of a 1-antitrypsin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of ai-antitrypsin aid in the diagnosis of cirrhosis of the liver and pulmonary emphysema. PROT1 CAL is an in vitro diagnostic product for the calibration of the al-antitrypsin (AIAT), C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin…

Read the full statement (131 words)

The A1AT method is an in vitro diagnostic test for the quantitative determination of a 1-antitrypsin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of ai-antitrypsin aid in the diagnosis of cirrhosis of the liver and pulmonary emphysema.

PROT1 CAL is an in vitro diagnostic product for the calibration of the al-antitrypsin (AIAT), C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), 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 al-antitrypsin (AlAT), C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG2 , immunoglobulin M (IGM), and prealbumin (PREALB) on the Dimension Vista System.

Indications for use as stated in the FDA summary.

Also cleared against K053072

1 other device cites the same predicate.

  • K063663Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M and HDade Behring, Inc. · 2007

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 DEM

The DEM category page

  • K123256Human Alpha-1 Antitrypsin Kit SpaplusThe Binding Site Group, Ltd. · 20131 recall
  • K053072N Antisera to Human ALPHA1-AntitrypsinDade Behring, Inc. · 2006
  • K052819Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers I, II and IiiOrtho-Clinical Diagnostics, Inc. · 2005
  • K050596Quantia A1-atBiokit, S.A. · 2005
  • K031857Advia Chemistry Alpha-1 Antitrypsin AssayBayer Diagnostics Corp. · 2003

https://510kreport.com/device/K063610 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063610: Dimension Vista A1AT Flex Reagent Cartridge and Protein 1 Calibrator and Control Medium and High.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063610

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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