Cleared Traditional

K851286 - RADIAL IMMUNODIFFUSION PLATES C3 & C4

K851286 is the FDA 510(k) clearance for RADIAL IMMUNODIFFUSION PLATES C3 & C4 by Cooper Biomedical, Inc.. It is a Class 2 Immunology device (product code CZW) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K851286 · Cooper Biomedical, Inc. · Immunology device
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Jun 1985
Decision
65d
Days
Class 2
Risk

K851286 is an FDA 510(k) clearance for the RADIAL IMMUNODIFFUSION PLATES C3 & C4. Classified as Complement C3, Antigen, Antiserum, Control (product code CZW), Class II - Special Controls.

Submitted by Cooper Biomedical, Inc. (Malvern, US). The FDA issued a Cleared decision on June 5, 1985 after a review of 65 days - a notably fast clearance 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: 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 K851286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1985
Decision Date June 05, 1985
Days to Decision 65 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 104d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 33
Devices cleared under the same product code (CZW) and FDA review panel - the closest regulatory comparables to K851286.
QM300 C3 ANTIBODY PACK
K871939 · Kallestad Diag, A Div. of Erbamont, Inc. · Jun 1987
PRECIMAT(R) C3
K871024 · Boehringer Mannheim Corp. · May 1987
DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY
K871346 · Dako Corp. · Apr 1987
C3 ANTISERUM CONTROL
K834604 · Technicon Instruments Corp. · Jan 1984
RABBITT ANTISERUM TO HUMAN C3C
K831905 · Dako Corp. · Jul 1983
IMMUNOGL. FRCT. OF RABBIT ANTISER.-C3
K812491 · Dako Corp. · Sep 1981