Cleared Traditional

CRP HS TEST SYSTEM (K003400) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

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Submission Details

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
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 104d · This submission: 190d
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 69
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K003400.
CardioPhase® hsCRP
K232624 · Siemens Healthcare Diagnostic Products GmbH · Nov 2023
RCRP Flex reagent cartridge
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Tina-quant C-Reactive Protein IV
K192072 · Roche Diagnostics Operations (Rdo) · Feb 2020
Optilite High Sensitivity C-Reactive Protein Kit
K180099 · The Binding Site Group , Ltd. · Oct 2018
Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
K172868 · The Binding Site Group , Ltd. · Feb 2018