Cleared Traditional

K050665 - N ANTISERA TO HUMAN COMPLEMENT FACTORS ...

K050665 is the FDA 510(k) clearance for N ANTISERA TO HUMAN COMPLEMENT FACTORS ... by Dade Behring, Inc.. It is a Class 2 Immunology device (product code CZW) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K050665 · Dade Behring, Inc. · Immunology device
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May 2005
Decision
48d
Days
Class 2
Risk

K050665 is an FDA 510(k) clearance for the N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4). Classified as Complement C3, Antigen, Antiserum, Control (product code CZW), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on May 2, 2005 after a review of 48 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K050665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2005
Decision Date May 02, 2005
Days to Decision 48 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
56d faster than avg
Panel avg: 104d · This submission: 48d
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 28
Devices cleared under the same product code (CZW) and FDA review panel - the closest regulatory comparables to K050665.
DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH
K061852 · Dade Behring, Inc. · Sep 2006
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
WAKO AUTOKIT C3
K010326 · Wako Chemicals USA, Inc. · Jun 2001
RANDOX COMPLEMENT C3
K000469 · Randox Laboratories, Ltd. · Mar 2000
DIMENSION C3 FLEX REAGENT CARTRIDGE
K994296 · Dade Behring, Inc. · Mar 2000