Cleared Traditional

K822341 - ALLERGENETICS IGE-FAST TEST

K822341 is the FDA 510(k) clearance for ALLERGENETICS IGE-FAST TEST by Allergenetics. It is a Class 2 Immunology device (product code DGC) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K822341 · Allergenetics · Immunology device
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Nov 1982
Decision
98d
Days
Class 2
Risk

K822341 is an FDA 510(k) clearance for the ALLERGENETICS IGE-FAST TEST. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Allergenetics (Walker, US). The FDA issued a Cleared decision on November 10, 1982 after a review of 98 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

Submission Details

510(k) Number K822341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1982
Decision Date November 10, 1982
Days to Decision 98 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 104d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 84
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K822341.
PHADEZYM RAST ALLERGEN DISCS
K823842 · Pharmacia, Inc. · Jan 1983
TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY
K823507 · Hybritech, Inc. · Dec 1982
ALLERCOAT POSITIVE CONTROL SERUM
K823403 · Kallestad Laboratories, Inc. · Dec 1982
RAST ALLERCOAT ALLERGEN DISCS
K822613 · Kallestad Laboratories, Inc. · Oct 1982
VAST VENTREX RAST ALLERGEN DISCS
K822442 · Ventrex Laboratories, Inc. · Sep 1982
TOTAL IGE DISCS
K822206 · Kallestad Laboratories, Inc. · Aug 1982