Cleared Traditional

K864512 - IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO

K864512 is an FDA 510(k) clearance for IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/..., manufactured by Cooper Biomedical, Inc.. The device is a Class 2 Immunology device with product code DAD cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K864512 · Cooper Biomedical, Inc. · Immunology device
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Feb 1987
Decision
92d
Days
Class 2
Risk

K864512 is an FDA 510(k) clearance for the IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO. Classified as Haptoglobin, Antigen, Antiserum, Control (product code DAD), Class II - Special Controls.

Submitted by Cooper Biomedical, Inc. (Malvern, US). The FDA issued a Cleared decision on February 13, 1987 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5460 - 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 Cooper Biomedical, Inc. devices

FDA 510(k) Submission Details - K864512

510(k) Number K864512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1986
Decision Date February 13, 1987
Days to Decision 92 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 105d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DAD Device Classification - Class 2, Special Controls

Product Code DAD Haptoglobin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5460
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 - DAD Haptoglobin, Antigen, Antiserum, Control

All 14
Devices cleared under the same product code (DAD) and FDA review panel - the closest regulatory comparables to K864512.
SPQ(TM) ANTIBODY REAGENT SET II FOR HPT
K890562 · Atlantic Antibodies · Feb 1989
HAPTOGLOBIN
K873866 · Unipath , Ltd. · Oct 1987
QM300 HAPTOGLOBIN ANTIBODY PACK
K872717 · Kallestad Diag, A Div. of Erbamont, Inc. · Jul 1987
DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB
K831957 · Kent Laboratories, Inc. · Jul 1983
IMMUNOGL. FRCT. OF RABBIT ANTISER.-HAPTO
K812494 · Dako Corp. · Sep 1981
HAPTOGLOBIN NEPHELOMETRIC ASSAY
K801433 · J.T. Baker Chemical Co. · Jul 1980