Cleared Traditional

K053074 - N ANTISERA TO HUMAN CERULOPLASMIN

K053074 is an FDA 510(k) clearance for N ANTISERA TO HUMAN CERULOPLASMIN, manufactured by Dade Behring, Inc.. The device is a Class 2 Immunology device with product code DDB cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K053074 · Dade Behring, Inc. · Immunology device
Download Printable Device Report (PDF)
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Mar 2006
Decision
135d
Days
Class 2
Risk

K053074 is an FDA 510(k) clearance for the N ANTISERA TO HUMAN CERULOPLASMIN. Classified as Ceruloplasmin, Antigen, Antiserum, Control (product code DDB), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on March 16, 2006 after a review of 135 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 Dade Behring, Inc. devices

FDA 510(k) Submission Details - K053074

510(k) Number K053074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2005
Decision Date March 16, 2006
Days to Decision 135 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
30d slower than avg
Panel avg: 105d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DDB Device Classification - Class 2, Special Controls

Product Code DDB Ceruloplasmin, Antigen, Antiserum, Control
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.

Regulatory Peers - DDB Ceruloplasmin, Antigen, Antiserum, Control

All 17
Devices cleared under the same product code (DDB) and FDA review panel - the closest regulatory comparables to K053074.
HUMAN CAERULOPLASMIN KIT
K122965 · The Binding Site Group , Ltd. · Jun 2013
IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT
K964762 · Beckman Instruments, Inc. · Apr 1997
CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT
K913668 · The Binding Site, Ltd. · Dec 1991
QM300 CERULOPLASMIN ANTIBODY PACK
K895377 · Kallestad Diag, A Div. of Erbamont, Inc. · Sep 1989
NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM
K860138 · Sigma Diagnostics, Inc. · Mar 1986
72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL
K850682 · Kent Laboratories, Inc. · Nov 1985