Cleared Traditional

K063086 - TRANSFERRIN

K063086 is the FDA 510(k) clearance for TRANSFERRIN by Thermo Electron OY. It is a Class 2 Immunology device (product code DDG) cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K063086 · Thermo Electron OY · Immunology device
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Aug 2007
Decision
302d
Days
Class 2
Risk

K063086 is an FDA 510(k) clearance for the TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS. Classified as Transferrin, Antigen, Antiserum, Control (product code DDG), Class II - Special Controls.

Submitted by Thermo Electron OY (Vantaa, FI). The FDA issued a Cleared decision on August 8, 2007 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5880 - 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. Elevated predicate reliance profile. 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 Thermo Electron OY devices

Submission Details

510(k) Number K063086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2006
Decision Date August 08, 2007
Days to Decision 302 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
198d slower than avg
Panel avg: 104d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DDG Transferrin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5880
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 - DDG Transferrin, Antigen, Antiserum, Control

All 39
Devices cleared under the same product code (DDG) and FDA review panel - the closest regulatory comparables to K063086.
TRANSFERRIN KIT FOR USE ON THE SPAPLUS
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K080634 · Beckman Coulter, Inc. · Aug 2008
DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA
K081299 · Siemens Healthcare Diagnostics, Inc. · Aug 2008
DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H
K063663 · Dade Behring, Inc. · Mar 2007
DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H
K063322 · Dade Behring, Inc. · Jan 2007
N ANTISERA TO HUMAN TRANSFERRIN
K053075 · Dade Behring, Inc. · Mar 2006