Cleared Traditional

K061825 - DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE

K061825 is the FDA 510(k) clearance for DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE by Dade Behring, Inc.. It is a Class 2 Chemistry device (product code DCN) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K061825 · Dade Behring, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Sep 2006
Decision
70d
Days
Class 2
Risk

K061825 is an FDA 510(k) clearance for the DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LO.... Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on September 6, 2006 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5270 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K061825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2006
Decision Date September 06, 2006
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 88d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DCN System, Test, C-reactive Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - DCN System, Test, C-reactive Protein

All 33
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K061825.
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
K171498 · Meso Scale Diagnostics, LLC · Jan 2018
C-REACTIVE PROTEIN (LATEX)
K083444 · Roche Diagnostics Corp. · Mar 2009
ROCHE-CREACTIVE PROTEIN (LATEX)
K073277 · Roche Diagnostics Corp. · Mar 2008
TINA-QUANT CRP (LATEX)
K032336 · Roche Diagnostics Corp. · Aug 2003
C-REACTIVE PROTEIN (CRP)
K030899 · Abbott Laboratories · Jul 2003
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT
K021572 · Beckman Coulter, Inc. · Jul 2002