Cleared Traditional

K863868 - IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT

K863868 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 DFF cleared through the Traditional 510(k) pathway after a 133-day FDA review.

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

FDA 510(k) Submission Details - K863868

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 105d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DFF Device Classification - Class 2, Special Controls

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.