Cleared Traditional

K003419 - RCRP FLEX REAGENT CARTRIDGE

K003419 is the FDA 510(k) clearance for RCRP FLEX REAGENT CARTRIDGE by Dade Behring, Inc.. It is a Class 2 Immunology device (product code DCN) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K003419 · Dade Behring, Inc. · Immunology device
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Feb 2001
Decision
104d
Days
Class 2
Risk

K003419 is an FDA 510(k) clearance for the RCRP FLEX REAGENT CARTRIDGE. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Dade Behring, Inc. (P.O. Box 6101, Newark, US). The FDA issued a Cleared decision on February 14, 2001 after a review of 104 days - within the typical 510(k) review window.

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

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K003419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2000
Decision Date February 14, 2001
Days to Decision 104 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 104d · This submission: 104d
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 Immunology 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 K003419.
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT
K021572 · Beckman Coulter, Inc. · Jul 2002
BAYER ADVIA IMS SYSTEM
K012337 · Bayer Corp. · Dec 2001
CRP HS TEST SYSTEM
K003400 · Roche Diagnostics Corp. · May 2001
WAKO CRP-UL, CRP-UL CALIBRATOR SET
K003342 · Wako Chemicals USA, Inc. · Jan 2001
IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP
K003372 · Diagnostic Products Corp. · Dec 2000
OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
K002918 · Olympus America, Inc. · Oct 2000