Cleared Traditional

K822341 - ALLERGENETICS IGE-FAST TEST

K822341 is an FDA 510(k) clearance for ALLERGENETICS IGE-FAST TEST, manufactured by Allergenetics. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K822341

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
7d faster than avg
Panel avg: 105d · This submission: 98d
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 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