Cleared Traditional

K062114 - CERULOPLASMIN, MODEL 2055953

K062114 is an FDA 510(k) clearance for CERULOPLASMIN, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Immunology device with product code CHN cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K062114 · Roche Diagnostics Corp. · Immunology device
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Jan 2007
Decision
191d
Days
Class 2
Risk

K062114 is an FDA 510(k) clearance for the CERULOPLASMIN, MODEL 2055953. Classified as Immunochemical, Ceruloplasmin (product code CHN), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 31, 2007 after a review of 191 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5210 - 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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FDA 510(k) Submission Details - K062114

510(k) Number K062114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2006
Decision Date January 31, 2007
Days to Decision 191 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
86d slower than avg
Panel avg: 105d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CHN Device Classification - Class 2, Special Controls

Product Code CHN Immunochemical, Ceruloplasmin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5210
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.