Cleared Traditional

K833419 - LABELED 125I ANTI-IGE

K833419 is an FDA 510(k) clearance for LABELED 125I ANTI-IGE, manufactured by Allergenetics. The device is a Class 2 Immunology device with product code DGC cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K833419 · Allergenetics · Immunology device
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Feb 1984
Decision
123d
Days
Class 2
Risk

K833419 is an FDA 510(k) clearance for the LABELED 125I ANTI-IGE. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Allergenetics (Mchenry, US). The FDA issued a Cleared decision on February 3, 1984 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 866.5510 - 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: 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 Allergenetics devices

FDA 510(k) Submission Details - K833419

510(k) Number K833419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1983
Decision Date February 03, 1984
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
18d slower than avg
Panel avg: 105d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DGC Device Classification - Class 2, Special Controls

Product Code DGC Ige, 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 - DGC Ige, Antigen, Antiserum, Control

All 91
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K833419.
PHADEXACT SERUM, TOTAL IGE CONTROLS
K840476 · Pharmacia, Inc. · May 1984
SENSIBEAD EIA IGE KIT
K840674 · Terumo Medical Corp. · Apr 1984
PHADEXACT SERUM, ALLERGEN SPECIFIC IGE
K840538 · Pharmacia, Inc. · Mar 1984
ABBOTT IGE EIA
K832360 · Abbott Laboratories · Oct 1983
ALLERGEN CONTROL INHALENT
K832218 · Ventrex Laboratories, Inc. · Sep 1983
ALLERCOAT ALLERGEN DISCS
K831326 · Kallestad Laboratories, Inc. · Jun 1983