Cleared Traditional

K083444 - C-REACTIVE PROTEIN (LATEX)

K083444 is an FDA 510(k) clearance for C-REACTIVE PROTEIN (LATEX), 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 117-day FDA review.

K083444 · Roche Diagnostics Corp. · Immunology device
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Mar 2009
Decision
117d
Days
Class 2
Risk

K083444 is an FDA 510(k) clearance for the C-REACTIVE PROTEIN (LATEX). 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 March 18, 2009 after a review of 117 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 Roche Diagnostics Corp. devices

FDA 510(k) Submission Details - K083444

510(k) Number K083444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2008
Decision Date March 18, 2009
Days to Decision 117 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
12d slower than avg
Panel avg: 105d · This submission: 117d
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 K083444.
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K083040 · Alfa Wassermann Diagnostic Technologies, Inc. · Jan 2009
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K061825 · Dade Behring, Inc. · Sep 2006