Cleared Traditional

K963974 - IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMU...

K963974 is an FDA 510(k) clearance for IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMU..., 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 155-day FDA review.

K963974 · Beckman Instruments, Inc. · Immunology device
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Optimized for regulatory review, auditing and printing
Mar 1997
Decision
155d
Days
Class 2
Risk

K963974 is an FDA 510(k) clearance for the IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN. 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 March 6, 1997 after a review of 155 days - an extended review 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: 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 - K963974

510(k) Number K963974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1996
Decision Date March 06, 1997
Days to Decision 155 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
51d slower than avg
Panel avg: 104d · This submission: 155d
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 K963974.
WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
K993928 · Wako Chemicals USA, Inc. · Jan 2000
K-ASSAY IGG
K993281 · Kamiya Biomedical Co. · Nov 1999
IGG
K983221 · Abbott Laboratories · Nov 1998
SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT
K965108 · Beckman Instruments, Inc. · Mar 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)
K963868 · Beckman Instruments, Inc. · Feb 1997
QUANTEX IGG
K962202 · Instrumentation Laboratory CO · Sep 1996