Cleared Traditional

K964762 - IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLA...

K964762 is an FDA 510(k) clearance for IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLA..., manufactured by Beckman Instruments, Inc.. The device is a Class 2 Immunology device with product code DDB cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K964762 · Beckman Instruments, Inc. · Immunology device
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Apr 1997
Decision
149d
Days
Class 2
Risk

K964762 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT. Classified as Ceruloplasmin, Antigen, Antiserum, Control (product code DDB), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on April 25, 1997 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5210 - 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 - K964762

510(k) Number K964762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1996
Decision Date April 25, 1997
Days to Decision 149 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
45d slower than avg
Panel avg: 104d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DDB Device Classification - Class 2, Special Controls

Product Code DDB Ceruloplasmin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5210
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 - DDB Ceruloplasmin, Antigen, Antiserum, Control

All 16
Devices cleared under the same product code (DDB) and FDA review panel - the closest regulatory comparables to K964762.
HUMAN CAERULOPLASMIN KIT
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N ANTISERA TO HUMAN CERULOPLASMIN
K053074 · Dade Behring, Inc. · Mar 2006
CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT
K913668 · The Binding Site, Ltd. · Dec 1991
QM300 CERULOPLASMIN ANTIBODY PACK
K895377 · Kallestad Diag, A Div. of Erbamont, Inc. · Sep 1989
NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM
K860138 · Sigma Diagnostics, Inc. · Mar 1986
72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL
K850682 · Kent Laboratories, Inc. · Nov 1985