Cleared Traditional

K964260 - IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG

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
3d slower than avg
Panel avg: 105d · 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 56
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