Cleared Traditional

K003400 - CRP HS TEST SYSTEM

K003400 is an FDA 510(k) clearance for CRP HS TEST SYSTEM, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Immunology device with product code DCN cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K003400 · Roche Diagnostics Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
190d
Days
Class 2
Risk

K003400 is an FDA 510(k) clearance for the CRP HS TEST SYSTEM. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 10, 2001 after a review of 190 days - an extended review cycle.

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 Roche Diagnostics Corp. devices

FDA 510(k) Submission Details - K003400

510(k) Number K003400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2000
Decision Date May 10, 2001
Days to Decision 190 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
85d slower than avg
Panel avg: 105d · This submission: 190d
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 K003400.
C-REACTIVE PROTEIN (CRP)
K030899 · Abbott Laboratories · Jul 2003
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT
K021572 · Beckman Coulter, Inc. · Jul 2002
BAYER ADVIA IMS SYSTEM
K012337 · Bayer Corp. · Dec 2001
RCRP FLEX REAGENT CARTRIDGE
K003419 · Dade Behring, Inc. · Feb 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