Cleared Traditional

K800451 - GEMENI IGG ASSAY

K800451 is the FDA 510(k) clearance for GEMENI IGG ASSAY by Electro-Nucleonics Laboratories, Inc.. It is a Class 2 Immunology device (product code DEW) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K800451 · Electro-Nucleonics Laboratories, Inc. · Immunology device
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Apr 1980
Decision
55d
Days
Class 2
Risk

K800451 is an FDA 510(k) clearance for the GEMENI IGG ASSAY. Classified as Igg, Antigen, Antiserum, Control (product code DEW), Class II - Special Controls.

Submitted by Electro-Nucleonics Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 24, 1980 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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 Electro-Nucleonics Laboratories, Inc. devices

Submission Details

510(k) Number K800451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 1980
Decision Date April 24, 1980
Days to Decision 55 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
49d faster than avg
Panel avg: 104d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEW Igg, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - DEW Igg, Antigen, Antiserum, Control

All 54
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K800451.
IMMUNOLOGY CONTROL SERUM
K810056 · Icl Scientific · Feb 1981
J.T. BAKER IMMUNOGLOBULIN G NEPHELOMETRI
K801281 · J.T. Baker Chemical Co. · Jun 1980
RID SYSTEM-QUAD MULTITEST IGG, IGA,ETC.
K800897 · Icl Scientific · May 1980
IMMUNOGLOBULIN G REAGENT SYSTEM
K800119 · Calbiochem-Behring Corp. · Feb 1980
LANCER L-INA ANTI-IGG
K791403 · Sherwood Medical Co. · Oct 1979
ANTISERUM TO HUMAN IMMUNOGLOBULINS
K791824 · Icl Scientific · Oct 1979