510(k) Report

510(k) · Cleared

Cleared

Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator; Protein 3 Control

K061990510(k) TraditionalCleared Sep 19, 200668-day reviewClass II21 CFR 866.5040

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

Dade Behring, Inc. · DCF Albumin, Antigen, Antiserum, Control

Cleared on Sep 19, 2006 as substantially equivalent to K860894 (Behring Diagnostics, Inc., 1986) and 2 other predicates after a 68-day review. Its family tree reaches back 2 generations to 1996. 6 later devices descend from it.

Decided
Sep 19, 2006
Review
68 days
Class
Class II
Product code
DCF
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K955858 (1996). 5 ancestors in all, the oldest K860894 (1986). 6 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1986: 1 other ancestor2000: 1 other ancestor2007: 2 descendants cleared2008: 2 descendants cleared2009: 1 descendant cleared2023: 1 descendant clearedK955858 · N/T Protein Control SY/L, M and H · Behring Diagnostics, Inc. · 1996K991704 · N/T Protein Control LC · Dade Behring, Inc. · 19991990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 2 descendants K991704 · N/T Protein Control LC · Dade Behring, Inc. · 1999K955858 · N/T Protein Control SY/L, M and H · Behring Diagnostics, Inc. · 19960
  1. Root · 2 generations backK955858 N/T Protein Control SY/L, M and HBehring Diagnostics, Inc. · 1996
  2. 1 generation backK991704 N/T Protein Control LCDade Behring, Inc. · 1999
  3. This deviceK061990 Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3…Dade Behring, Inc. · 2006
  4. Descendant · cites it directly · 5 of its ownK063508 Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2…Dade Behring, Inc. · 2007
  5. Descendant · 2 generations on · 4 of its ownK072435 Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1…Dade Behring, Inc. · 2007
  6. Descendant · 3 generations on · 1 of its ownK083445 N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T…Siemens Healthcare Diagnostics · 2009 · Recalled
  7. Descendant · 3 generations on · 1 of its ownK073561 Dimension Vista System Immunoglobulin G Flex Reagent Cartridge…Dade Behring, Inc. · 2008
  8. Descendant · 4 generations on · 0 of its ownK233663 N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH · 2023

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2007: 22008: 22009: 12023: 1
2007high 2 (2007) · low 0 (2010)2026

Most influential descendants

Showing 5 of 6 · See all
  • K063508Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and…Dade Behring, Inc. · 2007 · cites it directly5descendants
  • K072435Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control HDade Behring, Inc. · 2007 · 2 generations on4descendants
  • K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LCSiemens Healthcare Diagnostics · 2009 · 3 generations on1descendant
  • K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc. · 2008 · 3 generations on1descendant
  • K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH · 2023 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K955858N/T Protein Control SY/L, M and HBehring Diagnostics, Inc.1996—
−1K991704N/T Protein Control LCDade Behring, Inc.1999—
0 (this device)K061990Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator…Dade Behring, Inc.2006—
+1K063508Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator…Dade Behring, Inc.2007—
+2K072435Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1…Dade Behring, Inc.2007—
+3K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control…Siemens Healthcare Diagnostics20092
+3K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension…Dade Behring, Inc.2008—
+4K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
200010
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
200820
200910
202310
FIG. 1 — Lineage of K061990, 1996–2023Source: 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 DCF? 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
*K860894Behring Nephelometer System
Summary page 1
…Immunology (82) and Clinical Chemistry (75) 3. Identification of the Legally Marketed Device: Dade Behring NAntiserum to Human Albumin - K860894 Dade Behring NProtein Standard SL - K012470 Dade Behring N/T Protein Control LC - K991704…
Behring Diagnostics, Inc.1986—
*K012470Modification to N Protein Standard SL
Summary page 1
…ry (75) 3. Identification of the Legally Marketed Device: Dade Behring NAntiserum to Human Albumin - K860894 Dade Behring NProtein Standard SL - K012470 Dade Behring N/T Protein Control LC - K991704…
Dade Behring, Inc.20011
*K991704N/T Protein Control LC
Summary page 1
…d Device: Dade Behring NAntiserum to Human Albumin - K860894 Dade Behring NProtein Standard SL - K012470 Dade Behring N/T Protein Control LC - K991704 0OU077 Dade Behrin…
Dade Behring, Inc.1999—

Also cleared against K860894: 16 other devices →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K063508Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and…Dade Behring, Inc.20075

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 10 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K063508 (Dade Behring, Inc., 2007) has gone furthest, with 5 descendants of its own.
  • 16 other devices also cite its predicate K860894.

How does its category compare?

All DCF devices

DCF Albumin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DCF

1in 2016

2009: 12010: 32011: 12012: 12013: 12014: 12015: 12016: 1
2007high 3 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DCF

167in 2010

2010: 167 days median
2007high 167 (2010)2026

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

Recalls per year · DCF

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

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

Adverse event reports per year · DCF

12in 2025

2008: 12017: 32018: 22019: 62020: 22021: 32022: 32023: 52024: 92025: 12
2007high 12 (2025) · low 0 (2007)2025

MAUDE reports naming product code DCF, 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
20070—00
20080—01
20091—00
2010316700
20111—00
20121—00
20131—00
20141—00
20151—00
20161—00
20170—03
20180—02
20190—16
20200—02
20210—03
20220—03
20230—05
20240—09
20250—012
20260—0—

What is it indicated for?

The MALB method is an in vitro diagnostic reagent for the quantitative determination of albumin in human urine on the Dimension Vista Tm System. Measurement of albumin aids in the diagnosis of kidney and intestinal disease.

Protein 3 Calibrator is an in vitro diagnostic product for the calibration of the Microalbumin (MALB) method on the Dimension Vista TM System.

Protein 3 Control is an assayed intralaboratory quality contro! for the assessment of precision and analytical bias in determination of Microalbumin (MALB) on the Dimension VistaTM System.

Indications for use as stated in the FDA summary.

Also cleared against K860894

16 other devices cite the same predicate.

  • K082503Dimension Vista LG Light Chains, Type Kappa, Dimension Vista LG Light Chains, Type Lambda, Dimension Vista…Siemens Healthcare Diagnostics · 20081 recall
  • K063608Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1 Calibrator and Control Medium and HighDade Behring, Inc. · 2007
  • K053072N Antisera to Human ALPHA1-AntitrypsinDade Behring, Inc. · 2006
  • K053073N Antisera to Human ALPHA2-MacroglobulinDade Behring, Inc. · 2006
  • K053074N Antisera to Human CeruloplasminDade Behring, Inc. · 2006
  • K050596Quantia A1-atBiokit, S.A. · 2005

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 DCF

The DCF category page

  • K153560Optilite Low Level Albumin KitThe Binding Site Group, Ltd. · 2016
  • K143118Human Microalbumin kit for use on SPAPLUSThe Binding Site Group, Ltd. · 2015
  • K142346Urine/CSF Albumin, Urine/CSF Albumin CalibratorBeckman Coulter Ireland, Inc. · 2014
  • K121045Human Albumin CSF KitThe Binding Site Group, Ltd. · 2013
  • K113072Tina-Quant Albumin Gen.2Roche Diagnostics Operations · 2012

https://510kreport.com/device/K061990 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061990: Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator; Protein 3 Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061990

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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