Cleared Traditional

K032014 - N LATEX IGM

K032014 is the FDA 510(k) clearance for N LATEX IGM by Dade Behring, Inc.. It is a Class 2 Immunology device (product code CFN) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K032014 · Dade Behring, Inc. · Immunology device
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Aug 2003
Decision
38d
Days
Class 2
Risk

K032014 is an FDA 510(k) clearance for the N LATEX 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 August 7, 2003 after a review of 38 days - a notably fast clearance cycle.

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: 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 K032014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2003
Decision Date August 07, 2003
Days to Decision 38 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
66d faster than avg
Panel avg: 104d · This submission: 38d
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 K032014.
DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY
K061338 · Dade Behring, Inc. · Jul 2006
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)
K042735 · Dade Behring, Inc. · Feb 2005
VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS
K042475 · Ortho-Clinical Diagnostics, Inc. · Nov 2004
HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER
K022083 · The Binding Site, Ltd. · Jul 2002
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB
K012292 · The Binding Site, Ltd. · Aug 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T
K012296 · The Binding Site, Ltd. · Aug 2001