Cleared Traditional

GOAT ANTI-HUMAN KAPPA AFFINITY (K832260) - FDA 510(k) Clearance

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

K832260 · Gelco Diagnostics, Inc. · Immunology device
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Oct 1983
Decision
123d
Days
Class 2
Risk

K832260 is an FDA 510(k) clearance for the GOAT ANTI-HUMAN KAPPA AFFINITY. Classified as Kappa, Fitc, Antigen, Antiserum, Control (product code DEO), Class II - Special Controls.

Submitted by Gelco Diagnostics, Inc. (Walker, US). The FDA issued a Cleared decision on October 31, 1983 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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 Gelco Diagnostics, Inc. devices

Submission Details

510(k) Number K832260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1983
Decision Date October 31, 1983
Days to Decision 123 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 104d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEO Kappa, Fitc, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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.