Cleared Traditional

K964260 - IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIG...

K964260 is an FDA 510(k) clearance for IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIG..., manufactured by Beckman Instruments, Inc.. The device is a Class 2 Immunology device with product code DFH cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K964260 · Beckman Instruments, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
108d
Days
Class 2
Risk

K964260 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCH.... Classified as Kappa, Antigen, Antiserum, Control (product code DFH), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on February 10, 1997 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K964260

510(k) Number K964260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1996
Decision Date February 10, 1997
Days to Decision 108 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
4d slower than avg
Panel avg: 104d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DFH Device Classification - Class 2, Special Controls

Product Code DFH Kappa, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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 - DFH Kappa, Antigen, Antiserum, Control

All 53
Devices cleared under the same product code (DFH) and FDA review panel - the closest regulatory comparables to K964260.
FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER
K023009 · The Binding Site, Ltd. · Jan 2003
KAPPA IMMAGE FREELITE KIT
K003669 · The Binding Site, Ltd. · Feb 2001
SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT
K002564 · The Binding Site, Ltd. · Oct 2000
BECKMAN KAPPA LIGHT CHAIN REAGENT (ADD'L CLAIMS)
K902484 · Beckman Instruments, Inc. · Jun 1990
BECKMAN LAMBDA LIGHT CHAIN REAGENT
K884597 · Beckman Instruments, Inc. · Dec 1988
BECKMAN KAPPA LIGHT CHAIN REAGENT
K884276 · Beckman Instruments, Inc. · Nov 1988