510(k) Report

510(k) · Cleared

Cleared

Dimension Vista B2MIC Flex Reagent Cartridge, Protein 1 Calibrator, Control Medium, Control High

K063272510(k) TraditionalCleared Jan 26, 200788-day reviewClass II21 CFR 866.5630

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

Dade Behring, Inc. · JZG System, Test, Beta-2-Microglobulin Immunological

Cleared on Jan 26, 2007 as substantially equivalent to K002731 (Dade Behring, Inc., 2000) and 2 other predicates after an 88-day review. Its family tree reaches back 2 generations to 2000.

Decided
Jan 26, 2007
Review
88 days
Class
Class II
Product code
JZG
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K002852 (2000). 5 ancestors in all, the oldest K002804 (2000). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor2000: 2 other ancestorsK002852 · N/T Protein Control SL · Dade Behring, Inc. · 2000K012468 · Modification to N/T Protein Control SL · Dade Behring, Inc. · 200120002002200420062008
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor 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 deviceK063272 Dimension Vista B2MIC Flex Reagent Cartridge, 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)K063272Dimension Vista B2MIC Flex Reagent Cartridge, Protein 1 Calibrator, Control…Dade Behring, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020
200110
FIG. 1 — Lineage of K063272, 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 JZG? 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
*K002731N Latex B2-Microglobulin
Summary page 1
…Immunology (82) and Clinical Chemistry (75) 3. Identification of the Legally Marketed Device: Dade Behring N Latex f32-Microglobulin - K002731 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468…
Dade Behring, Inc.2000—
*K012470Modification to N Protein Standard SL
Summary page 1
…(75) 3. Identification of the Legally Marketed Device: Dade Behring N Latex f32-Microglobulin - K002731 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468…
Dade Behring, Inc.20011
*K012468Modification to N/T Protein Control SL
Summary page 1
…Device: Dade Behring N Latex f32-Microglobulin - K002731 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468 ((10 Viii Dade…
Dade Behring, Inc.2001—

Also cleared against K002731: 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 7 years and passes through 1 company; a new generation was cleared every 5.4 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • 2 other devices also cite its predicate K002731.

How does its category compare?

All JZG devices

JZG System, Test, Beta-2-Microglobulin Immunological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · JZG

1in 2016

2007: 22009: 22012: 22016: 1
2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JZG

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

Recalls per year · JZG

1in 2024

2015: 12021: 12024: 1
2007high 1 (2015) · low 0 (2007)2026

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

Adverse event reports per year · JZG

1in 2024

2015: 502019: 12024: 1
2007high 50 (2015) · low 0 (2007)2025

MAUDE reports naming product code JZG, 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
20072—00
20080—00
20092—00
20100—00
20110—00
20122—00
20130—00
20140—00
20150—150
20161—00
20170—00
20180—00
20190—01
20200—00
20210—10
20220—00
20230—00
20240—11
20250—00
20260—0—

What is it indicated for?

The B2MIC method is an in vitro diagnostic test for the quantitative determination of β2-microglobulin in human serum, or heparinized or EDTA plasma on the Dimension Vista® System. Measurements of β2-microglobulin aid in the diagnosis of renal dysfunction. PROT1 CAL is an in vitro diagnostic product for the calibration of the β2-microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M…

Read the full statement (127 words)

The B2MIC method is an in vitro diagnostic test for the quantitative determination of β2-microglobulin in human serum, or heparinized or EDTA plasma on the Dimension Vista® System. Measurements of β2-microglobulin aid in the diagnosis of renal dysfunction.

PROT1 CAL is an in vitro diagnostic product for the calibration of the β2-microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (QGM) and Prealbumin / Transthyretin (PREALB) methods on the Dimension Vista System.

PROT1 CON M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of β2-microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin / transthyretin (PREALB) on the Dimension Vista® System.

Indications for use as stated in the FDA summary.

Also cleared against K002731

2 other devices cite the same predicate.

  • K110874Advia Chemistry Reagents, and Advia Chemistry B2-Microglobulin CalibratorSiemens Healthcare Diagnostics, Inc. · 2012
  • K083463Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator, Dimension Vista Protein 1…Siemens Healthcare Diagnostics · 20094 recalls

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 JZG

The JZG category page

  • K161297Beta-2-MicroglobulinBeckman Coulter Ireland, Inc. · 2016
  • K122066Human Beta-2 Microglobulin Urine Kit for Use on the SpaplusThe Binding Site Group, Ltd. · 20121 recall
  • K110874Advia Chemistry Reagents, and Advia Chemistry B2-Microglobulin CalibratorSiemens Healthcare Diagnostics, Inc. · 2012
  • K083289Human Beta-2 Microglobulin KitThe Binding Site, Ltd. · 2009
  • K083463Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator, Dimension Vista Protein 1…Siemens Healthcare Diagnostics · 20094 recalls

https://510kreport.com/device/K063272 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063272: Dimension Vista B2MIC Flex Reagent Cartridge, Protein 1 Calibrator, Control Medium, Control High.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063272

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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