Cleared Traditional

K964842 - IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMEN...

K964842 is an FDA 510(k) clearance for IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMEN..., manufactured by Beckman Instruments, Inc.. The device is a Class 2 Immunology device with product code CZW cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K964842 · Beckman Instruments, Inc. · Immunology device
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Jun 1997
Decision
190d
Days
Class 2
Risk

K964842 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT. Classified as Complement C3, Antigen, Antiserum, Control (product code CZW), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on June 11, 1997 after a review of 190 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - 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 - K964842

510(k) Number K964842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1996
Decision Date June 11, 1997
Days to Decision 190 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
86d slower than avg
Panel avg: 104d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CZW Device Classification - Class 2, Special Controls

Product Code CZW Complement C3, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 - CZW Complement C3, Antigen, Antiserum, Control

All 34
Devices cleared under the same product code (CZW) and FDA review panel - the closest regulatory comparables to K964842.
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
K991907 · Bayer Corp. · Nov 1999
C3
K983441 · Abbott Laboratories · Nov 1998
N-ASSAY TIA MULTI V-NL
K964298 · Crestat Diagnostics, Inc. · Jul 1997
OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT
K962409 · Olympus America, Inc. · Oct 1996
QUANTEX C3
K962199 · Instrumentation Laboratory CO · Sep 1996
N PROTEIN STANDARS SY
K955857 · Behring Diagnostics, Inc. · Feb 1996