Cleared Traditional

K042735 - N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)

K042735 is an FDA 510(k) clearance for N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, manufactured by Dade Behring, Inc.. The device is a Class 2 Immunology device with 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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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K042735

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
32d slower than avg
Panel avg: 105d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFN Device Classification - Class 2, Special Controls

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 55
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