Cleared Traditional

K003419 - RCRP FLEX REAGENT CARTRIDGE

K003419 is an FDA 510(k) clearance for RCRP FLEX REAGENT CARTRIDGE, manufactured by Dade Behring, Inc.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K003419

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
1d faster than avg
Panel avg: 105d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCN Device Classification - Class 2, Special Controls

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 46
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