Cleared Traditional

K063150 - COMPLEMENT C3 AND C4

K063150 is the FDA 510(k) clearance for COMPLEMENT C3 AND C4 by Thermo Electron OY. It is a Class 2 Immunology device (product code CZW) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K063150 · Thermo Electron OY · Immunology device
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Mar 2007
Decision
154d
Days
Class 2
Risk

K063150 is an FDA 510(k) clearance for the COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL. Classified as Complement C3, Antigen, Antiserum, Control (product code CZW), Class II - Special Controls.

Submitted by Thermo Electron OY (Vantaa, FI). The FDA issued a Cleared decision on March 19, 2007 after a review of 154 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - 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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Submission Details

510(k) Number K063150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2006
Decision Date March 19, 2007
Days to Decision 154 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 104d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CZW Complement C3, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 - CZW Complement C3, Antigen, Antiserum, Control

All 33
Devices cleared under the same product code (CZW) and FDA review panel - the closest regulatory comparables to K063150.
SPAPLUS
K100179 · The Binding Site Group , Ltd. · Aug 2010
DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH
K061852 · Dade Behring, Inc. · Sep 2006
N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)
K050665 · Dade Behring, Inc. · May 2005
VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III
K042494 · Ortho-Clinical Diagnostics · Oct 2004
SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI
K032035 · Beckman Coulter, Inc. · Aug 2003
TINA-QUANT COMPLEMENT C3C TEST SYSTEM
K012361 · Roche Diagnostics Corp. · Nov 2001