Cleared Traditional

IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT (K863868) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K863868 · Cooper Biomedical, Inc. · Immunology device
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Feb 1987
Decision
133d
Days
Class 2
Risk

K863868 is an FDA 510(k) clearance for the IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT. Classified as Alpha-1-antichymotrypsin, Antigen, Antiserum, Control (product code DFF), 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 133 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5080 - 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

Submission Details

510(k) Number K863868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1986
Decision Date February 13, 1987
Days to Decision 133 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 104d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFF Alpha-1-antichymotrypsin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5080
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.