Cleared Traditional

K051456 - SENTINEL CERULOPLASMIN

K051456 is an FDA 510(k) clearance for SENTINEL CERULOPLASMIN, manufactured by Sentinel Ch. Srl. The device is a Class 2 Immunology device with product code JFR cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K051456 · Sentinel Ch. Srl · Immunology device
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Oct 2005
Decision
141d
Days
Class 2
Risk

K051456 is an FDA 510(k) clearance for the SENTINEL CERULOPLASMIN. Classified as Indirect Copper Assay, Ceruloplasmin (product code JFR), Class II - Special Controls.

Submitted by Sentinel Ch. Srl (Milano, IT). The FDA issued a Cleared decision on October 21, 2005 after a review of 141 days - within the typical 510(k) review window.

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.

View all Sentinel Ch. Srl devices

FDA 510(k) Submission Details - K051456

510(k) Number K051456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2005
Decision Date October 21, 2005
Days to Decision 141 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
36d slower than avg
Panel avg: 105d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFR Device Classification - Class 2, Special Controls

Product Code JFR Indirect Copper Assay, 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.