510(k) Report

510(k) · Cleared

Cleared

Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control H

K072435510(k) TraditionalCleared Oct 17, 200748-day reviewClass II21 CFR 862.1150

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

Dade Behring, Inc. · JIX Calibrator, Multi-Analyte Mixture

Cleared on Oct 17, 2007 as substantially equivalent to K063508 (Dade Behring, Inc., 2007) and 1 other predicate after a 48-day review. Its family tree reaches back 5 generations to 2000. 4 later devices descend from it.

Decided
Oct 17, 2007
Review
48 days
Class
Class II
Product code
JIX
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K002852 (2000). 19 ancestors in all, the oldest K860894 (1986). 4 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2006: 3 other ancestors2001: 1 other ancestor2003: 1 other ancestor2000: 2 other ancestors1999: 1 other ancestor1997: 1 other ancestor1996: 2 other ancestors1986: 1 other ancestor2005: 1 other ancestor2008: 2 descendants cleared2009: 1 descendant cleared2023: 1 descendant clearedK002852 · N/T Protein Control SL · Dade Behring, Inc. · 2000K012468 · Modification to N/T Protein Control SL · Dade Behring, Inc. · 2001×2: 2 generations cleared close together, K061338 (2006), K062055 (2006) K063508 · Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and Control L, H; Protein 3 Calibrator an · Dade Behring, Inc. · 20071990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 4 other ancestors3 generations back: 6 other ancestors4 generations back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants K063508 · Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and Control L, H; Protein 3 Calibrator an · Dade Behring, Inc. · 2007K062055 · Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control High · Dade Behring, Inc. · 2006K061338 · Dimension Vista Iga Flex Reagent Cartridge Assay · Dade Behring, Inc. · 2006K012468 · Modification to N/T Protein Control SL · Dade Behring, Inc. · 2001K002852 · N/T Protein Control SL · Dade Behring, Inc. · 2000−50
  1. Root · 5 generations backK002852 N/T Protein Control SLDade Behring, Inc. · 2000
  2. 4 generations backK012468 Modification to N/T Protein Control SLDade Behring, Inc. · 2001
  3. 3 generations backK061338 Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc. · 2006
  4. 2 generations backK062055 Dimension Vista Protein 1 Calibrator, Control Low, Control Medium…Dade Behring, Inc. · 2006
  5. 1 generation backK063508 Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2…Dade Behring, Inc. · 2007
  6. This deviceK072435 Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1…Dade Behring, Inc. · 2007
  7. Descendant · cites it directly · 1 of its ownK083445 N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T…Siemens Healthcare Diagnostics · 2009 · Recalled
  8. Descendant · cites it directly · 1 of its ownK073561 Dimension Vista System Immunoglobulin G Flex Reagent Cartridge…Dade Behring, Inc. · 2008
  9. Descendant · 2 generations on · 0 of its ownK233663 N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH · 2023
  10. Descendant · 2 generations on · 0 of its ownK081161 Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista…Dade Behring, Inc. · 2008

Most influential descendants

Showing 4 of 4 · See all
  • K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LCSiemens Healthcare Diagnostics · 2009 · cites it directly1descendant
  • K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc. · 2008 · cites it directly1descendant
  • K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH · 2023 · 2 generations on0descendants
  • K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1…Dade Behring, Inc. · 2008 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K002852N/T Protein Control SLDade Behring, Inc.2000—
−4K012468Modification to N/T Protein Control SLDade Behring, Inc.2001—
−3K061338Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc.2006—
−2K062055Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control HighDade Behring, Inc.2006—
−1K063508Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator…Dade Behring, Inc.2007—
0 (this device)K072435Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1…Dade Behring, Inc.2007—
+1K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control…Siemens Healthcare Diagnostics20092
+1K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension…Dade Behring, Inc.2008—
+2K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH2023—
+2K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199620
199710
199910
200020
200110
200310
200510
200630
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
200910
202310
FIG. 1 — Lineage of K072435, 2000–2023Source: 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 JIX? 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? (2)

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
*K063508Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and…
Summary page 1
…Panel: Clinical Chemistry (75) 3. Identification of the Legally Marketed Device: Dimension Vista®0 Protein 3 Calibrator K063508 Dimension Vista®~Protein 3 Control K063508 Dimension Vista® Protein I Control L K063663…
Dade Behring, Inc.2007—
*K063663Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M…
Summary page 1
…Vista®0 Protein 3 Calibrator K063508 Dimension Vista®~Protein 3 Control K063508 Dimension Vista® Protein I Control L K063663 Page 1 of 4…
Dade Behring, Inc.2007—

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LCSiemens Healthcare Diagnostics20091
K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc.20081

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 9 months on median.
  • 2 of the 19 ancestors have a recall of any class.
  • Of its descendants, K083445 (Siemens Healthcare Diagnostics, 2009) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JIX devices

JIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · JIX

1in 2016

2007: 62008: 52009: 42010: 52011: 72012: 22013: 42014: 12015: 32016: 1
2007high 7 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JIX

29in 2015

2007: 53 days median2008: 69 days median2009: 121 days median2010: 100 days median2011: 77 days median2013: 50 days median2015: 29 days median
2007high 121 (2009) · low 29 (2015)2026

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

Recalls per year · JIX

7in 2023

2007: 22008: 32009: 22010: 12011: 22012: 12014: 12016: 12017: 12018: 12019: 12020: 22023: 72026 (partial year): 1
2007high 7 (2023) · low 0 (2013)2026

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

Adverse event reports per year · JIX

18in 2025

2007: 1402008: 1732009: 392011: 92012: 32013: 242014: 352015: 42016: 62017: 172018: 162019: 122020: 222021: 92022: 112023: 132024: 152025: 18
2007high 173 (2008) · low 0 (2010)2025

MAUDE reports naming product code JIX, 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
20076532140
20085693173
20094121239
2010510010
201177729
20122—13
2013450024
20141—135
201532904
20161—16
20170—117
20180—116
20190—112
20200—222
20210—09
20220—011
20230—713
20240—015
20250—018
20260—1—

What is it indicated for?

PROT3 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for the ao-Microglobulin (A1MIC), Cystatin C (CYSC), Microalbumin (MALB) and specialty Albumin (sALB)* methods. * For serum, plasma and cerebrospinal fluid PROT3 CON is an assayed intralaboratory quality control, for assessment of precision and analytical bias in the determination of a,-Micro.globulin (AlMIC), specialty Albumin (sALB) 1 and Microalbumin (MALB)…

Read the full statement (297 words)

PROT3 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for the ao-Microglobulin (A1MIC), Cystatin C (CYSC), Microalbumin (MALB) and specialty Albumin (sALB)* methods.

* For serum, plasma and cerebrospinal fluid

PROT3 CON is an assayed intralaboratory quality control, for assessment of precision and analytical bias in the determination of a,-Micro.globulin (AlMIC), specialty Albumin (sALB) 1 and Microalbumin (MALB) on the Dimension Vista System.

1For cerebrospinal fluid (CSF)

PROT1 CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of:

a,-Acid Glycoprotein (AIAG) Immunoglobulin E (IGE)

a1 -Antitrypsin (A1AT) Immunoglobulin G (IGG)

C3 Complement (C3) Immunoglobulin M(IGM)

C4 Complement (C4) Prealbumin (PREALB)

Ceruloplasmin (CER) specialty Albumin* (sALB)

Haptoglobin (HAPT) soluble Transferrin Receptor (STFR)

Homocysteine (HCYS) Transferrin (TRF)

Immunoglobulin A (IGA)

*For serum and plasma

PROT1 CON M 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:

a,-Acid Glycoprotein (A1AG) Immunoglobulin A (IGA)

a 1-Antitrypsin (AIAT) Immunoglobulin E (IGE)

132- Microglobulin (B2MIC) Immunoglobulin G (IGG)

C3 Complement (C3) Immunoglobulin M (IGM)

C4 Complement (C4) Prealbumin (PREALB)

Ceruloplasmin (CER) specialty Albumin* (sALB)

Haptoglobin (HAPT) soluble Transferrin Receptor (STFR)

Homocysteine (HCYS) Transferrin (TRF)

*For serum and plasma

PROT1 CON H is an assayed, high level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista System in the quantitative determination of:

a,-Acid Glycoprotein (A1AG) Immunoglobulin A (IGA)

o1 -Antitrypsin (A1AT) Immunoglobulin E (IGE)

P2- Microglobulin (B2MIC) Immunoglobulin G (IGG)

C3 Complement (C3) Immunoglobulin M (IGM)

C4 Complement (C4) Prealbumin (PREALB)

Ceruloplasmin (CER) specialty Albumin* (sALB)

Haptoglobin (HAPT) soluble Transferrin Receptor (STFR)

Homocysteine (HCYS) Transferrin (TRF)

*For serum and plasma

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 JIX

The JIX category page

  • K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc. · 2016
  • K153365ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 CalibratorSiemens Healthcare Diagnostics, Inc. · 2015
  • K151552ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL IIElitechgroup · 2015
  • K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)Siemens Healthcare Diagnostics · 20152 recalls
  • K141388System CalibraterBeckman Coulter Ireland, Inc. · 2014

https://510kreport.com/device/K072435 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072435: Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072435

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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