Cleared Traditional

K851283 - RADIAL IMMUNODIFFUSION PLATES-CERULOPLA...

K851283 is the FDA 510(k) clearance for RADIAL IMMUNODIFFUSION PLATES-CERULOPLA... by Cooper Biomedical, Inc.. It is a Class 2 Immunology device (product code DDB) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K851283 · Cooper Biomedical, Inc. · Immunology device
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May 1985
Decision
52d
Days
Class 2
Risk

K851283 is an FDA 510(k) clearance for the RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN. Classified as Ceruloplasmin, Antigen, Antiserum, Control (product code DDB), Class II - Special Controls.

Submitted by Cooper Biomedical, Inc. (Malvern, US). The FDA issued a Cleared decision on May 23, 1985 after a review of 52 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cooper Biomedical, Inc. devices

Submission Details

510(k) Number K851283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1985
Decision Date May 23, 1985
Days to Decision 52 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 104d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 17
Devices cleared under the same product code (DDB) and FDA review panel - the closest regulatory comparables to K851283.
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
LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS)
K852247 · Behring Diagnostics, Inc. · Jul 1985
QUANTIMETRIC 2 CERULOPLASMIN ASSAY
K823107 · Kallestad Laboratories, Inc. · Nov 1982
IMMUNOGL. FRCT. OF RABBIT ANTISER.-CERUL
K812486 · Dako Corp. · Sep 1981
J.T. BAKER CERULOPLASMIN NEPHELOMETRIC
K801661 · J.T. Baker Chemical Co. · Sep 1980