Cleared Traditional

K053109 - DIMENSION CARDIOPHASE HIGH SENSITIVITY ...

K053109 is the FDA 510(k) clearance for DIMENSION CARDIOPHASE HIGH SENSITIVITY ... by Dade Behring, Inc.. It is a Class 2 Chemistry device (product code NQD) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K053109 · Dade Behring, Inc. · Chemistry device
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Dec 2005
Decision
49d
Days
Class 2
Risk

K053109 is an FDA 510(k) clearance for the DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE. Classified as Cardiac C-reactive Protein, Antigen, Antiserum, And Control (product code NQD), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on December 23, 2005 after a review of 49 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 K053109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2005
Decision Date December 23, 2005
Days to Decision 49 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
39d faster than avg
Panel avg: 88d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NQD Cardiac C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
Definition In Vitro Diagnostic Test To Measure C-reactive Protein For The Purpose Of Making Cardiac Risk Assessments.
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 - NQD Cardiac C-reactive Protein, Antigen, Antiserum, And Control

All 16
Devices cleared under the same product code (NQD) and FDA review panel - the closest regulatory comparables to K053109.
DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH
K061802 · Dade Behring, Inc. · Sep 2006
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK
K060369 · Dade Behring, Inc. · May 2006
C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS
K053603 · Roche Diagnostics Corp. · Feb 2006
OLYMPUS CRP LATEX REAGENT, OSR6199
K051564 · Olympus America, Inc. · Aug 2005
TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)
K042485 · Roche Diagnostics Corp. · Oct 2004
VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS
K041799 · Ortho-Clinical Diagnostics, Inc. · Aug 2004