510(k) Report

510(k) · Cleared

Cleared

Dimension Vista CRP Flex Reagent Cartridge, Protein 2 Calibrator, Control Low and Control High

K061825510(k) TraditionalCleared Sep 6, 200670-day reviewClass II21 CFR 866.5270

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

Dade Behring, Inc. · DCN System, Test, C-Reactive Protein

Cleared on Sep 6, 2006 as substantially equivalent to K033908 (Dade Behring, Inc., 2004) and 2 other predicates after a 70-day review. Its family tree reaches back 2 generations to 1999.

Decided
Sep 6, 2006
Review
70 days
Class
Class II
Product code
DCN
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K991385 (1999). 4 ancestors in all, the oldest K962373 (1996). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1996: 1 other ancestorK991385 · Dade Behring N High Sensitivity CRP Assay · Dade Behring, Inc. · 1999K033908 · N High Sensitivity CRP · Dade Behring, Inc. · 20041996199820002002200420062008
Other ancestors, by generation 1 generation back: 2 other ancestors K033908 · N High Sensitivity CRP · Dade Behring, Inc. · 2004K991385 · Dade Behring N High Sensitivity CRP Assay · Dade Behring, Inc. · 19990
  1. Root · 2 generations backK991385 Dade Behring N High Sensitivity CRP AssayDade Behring, Inc. · 1999
  2. 1 generation backK033908 N High Sensitivity CRPDade Behring, Inc. · 2004
  3. This deviceK061825 Dimension Vista CRP Flex Reagent Cartridge, Protein 2 Calibrator…Dade Behring, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K991385Dade Behring N High Sensitivity CRP AssayDade Behring, Inc.1999—
−1K033908N High Sensitivity CRPDade Behring, Inc.2004—
0 (this device)K061825Dimension Vista CRP Flex Reagent Cartridge, Protein 2 Calibrator, Control Low…Dade Behring, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
FIG. 1 — Lineage of K061825, 1999–2006Source: 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 DCN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DCN device

  1. #1 K232624 CardioPhase® hsCRPscore 6.7 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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
*K033908N High Sensitivity CRP
Summary page 1
…el: Immunology (82) and Clinical Chemistry (75) 3. Identification of the Legally Marketed Device: Dade Behring CardioPhasee hsCRP - K033908 Dade Behring N Rheumatology Standard SL - K964527 Dade Behring N/T Rheumatology Control SL - K962373 === Pag…
Dade Behring, Inc.2004—
*K964527N Rheumatology Standard SL
Summary page 1
…(75) 3. Identification of the Legally Marketed Device: Dade Behring CardioPhasee hsCRP - K033908 Dade Behring N Rheumatology Standard SL - K964527 Dade Behring N/T Rheumatology Control SL - K962373 4. Device Description: Dimension Vista TM CR…
Behring Diagnostics, Inc.1997—
*K962373N/T Rheumatology Control SL/1 and SL/2
Summary page 1
…ce: Dade Behring CardioPhasee hsCRP - K033908 Dade Behring N Rheumatology Standard SL - K964527 Dade Behring N/T Rheumatology Control SL - K962373 4. Device Description: Dimension Vista TM CRP Flex® reagent cartridge Polystyrene particles coated w…
Behring Diagnostics, Inc.1996—

Also cleared against K033908: 10 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 4.2 years on median.
  • None of the 4 ancestors has a recall.
  • 10 other devices also cite its predicate K033908.

How does its category compare?

All DCN devices

DCN System, Test, C-Reactive Protein: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DCN

2in 2023

2007: 12008: 22009: 32010: 12012: 12017: 12018: 32020: 12023: 2
2007high 3 (2009) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DCN

234in 2018

2009: 111 days median2018: 234 days median
2007high 234 (2018) · low 111 (2009)2026

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

Recalls per year · DCN

1in 2020

2008: 12019: 12020: 12026 (partial year): 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · DCN

7in 2025

2010: 22011: 52012: 22014: 22015: 22016: 12018: 22019: 82021: 12022: 12023: 32024: 52025: 7
2007high 8 (2019) · low 0 (2007)2025

MAUDE reports naming product code DCN, 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
20082—10
2009311100
20101—02
20110—05
20121—02
20130—00
20140—02
20150—02
20160—01
20171—00
2018323402
20190—18
20201—10
20210—01
20220—01
20232—03
20240—05
20250—07
20260—1—

What is it indicated for?

The CRP method is an in vitro diagnostic test for the quantitative measurement of C-reactive protein (CRP) in human serum and heparinized plasma by means of particle enhanced immunonephelometry on the Dimension Vista TMSystem. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, are observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, and inflammatory…

Read the full statement (124 words)

The CRP method is an in vitro diagnostic test for the quantitative measurement of C-reactive protein (CRP) in human serum and heparinized plasma by means of particle enhanced immunonephelometry on the Dimension Vista TMSystem. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, are observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, and inflammatory disorders.

Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the C-reactive protein (CRP) method on the Dimension VistaTM System.

Protein 2 Control L and H are for use as assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of C-reactive protein (CRP) on the Dimension VistaTM System.

Indications for use as stated in the FDA summary.

Also cleared against K033908

10 other devices cite the same predicate.

  • K212559CardioPhase® hsCRPSiemens Healthcare Diagnostics Products GmbH · 2022
  • K081294Advia Chemistry Cardiophase High Sensitivity C-Reactive Protein (Hscrp), CalibratorsSiemens Healthcare Diagnostics, Inc. · 20082 recalls
  • K071002Immage Immunochemistry Systems High Sensitivity Cardiac C-Reactive Protein (CCRP) ReagentBeckman Coulter, Inc. · 2007
  • K070626Synchron Systems High Sensitivity Cardiac C-Reactive Protein (CRPH) ReagentBeckman Coulter, Inc. · 2007
  • K063057Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRPDiagnostic Products Corporation · 2006
  • K061802Dimension Vista Cardiophase Hscrp Flex Reagent Cartridge, Protein 2 Calibrator, Hscrp Control Low, Hscrp 1…Dade Behring, Inc. · 2006

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 DCN

The DCN category page

  • K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbH · 2023
  • K221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc. · 20232 recalls
  • K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo) · 2020
  • K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group, Ltd. · 2018
  • K172868Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein…The Binding Site Group, Ltd. · 20181 recall

https://510kreport.com/device/K061825 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061825: Dimension Vista CRP Flex Reagent Cartridge, Protein 2 Calibrator, Control Low and Control High.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061825

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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