Cleared Traditional

K963868 - IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLO...

K963868 is an FDA 510(k) clearance for IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLO..., manufactured by Beckman Instruments, Inc.. The device is a Class 2 Immunology device with product code DEW cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K963868 · Beckman Instruments, Inc. · Immunology device
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Feb 1997
Decision
137d
Days
Class 2
Risk

K963868 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM). Classified as Igg, Antigen, Antiserum, Control (product code DEW), 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 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K963868

510(k) Number K963868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1996
Decision Date February 10, 1997
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
33d slower than avg
Panel avg: 104d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DEW Device Classification - Class 2, Special Controls

Product Code DEW Igg, Antigen, Antiserum, Control
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 - DEW Igg, Antigen, Antiserum, Control

All 55
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K963868.
IGG
K983221 · Abbott Laboratories · Nov 1998
IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN
K963974 · Beckman Instruments, Inc. · Mar 1997
SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT
K965108 · Beckman Instruments, Inc. · Mar 1997
QUANTEX IGG
K962202 · Instrumentation Laboratory CO · Sep 1996
IGG IMMUNOTURBIDIMETRIC & CALIBRATOR
K955798 · Randox Laboratories, Ltd. · Apr 1996
BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL
K951635 · Beckman Instruments, Inc. · May 1995