Cleared Traditional

K042735 - N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG

K042735 is the FDA 510(k) clearance for N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG by Dade Behring, Inc.. It is a Class 2 Immunology device (product code CFN) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K042735 · Dade Behring, Inc. · Immunology device
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Feb 2005
Decision
137d
Days
Class 2
Risk

K042735 is an FDA 510(k) clearance for the N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM). Classified as Method, Nephelometric, Immunoglobulins (g, A, M) (product code CFN), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on February 15, 2005 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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

Submission Details

510(k) Number K042735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2004
Decision Date February 15, 2005
Days to Decision 137 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
33d slower than avg
Panel avg: 104d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFN Method, Nephelometric, Immunoglobulins (g, A, M)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - CFN Method, Nephelometric, Immunoglobulins (g, A, M)

All 42
Devices cleared under the same product code (CFN) and FDA review panel - the closest regulatory comparables to K042735.
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER
K072889 · The Binding Site, Ltd. · Feb 2008
DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H
K061845 · Dade Behring, Inc. · Aug 2006
DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY
K061338 · Dade Behring, Inc. · Jul 2006
VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS
K042475 · Ortho-Clinical Diagnostics, Inc. · Nov 2004
N LATEX IGM
K032014 · Dade Behring, Inc. · Aug 2003
HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER
K022083 · The Binding Site, Ltd. · Jul 2002