Cleared Traditional

K042152 - BINDING SITE IGG SUBLCASS OLYMPUS KITS

K042152 is an FDA 510(k) clearance for BINDING SITE IGG SUBLCASS OLYMPUS KITS, manufactured by The Binding Site. The device is a Class 2 Immunology device with product code CFN cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K042152 · The Binding Site · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
105d
Days
Class 2
Risk

K042152 is an FDA 510(k) clearance for the BINDING SITE IGG SUBLCASS OLYMPUS KITS. Classified as Method, Nephelometric, Immunoglobulins (g, A, M) (product code CFN), Class II - Special Controls.

Submitted by The Binding Site (Santa Monica, US). The FDA issued a Cleared decision on November 22, 2004 after a review of 105 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 The Binding Site devices

FDA 510(k) Submission Details - K042152

510(k) Number K042152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2004
Decision Date November 22, 2004
Days to Decision 105 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 104d · This submission: 105d
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 K042152.
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
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
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