Cleared Traditional

K863394 - RAPID SPECIFIC IGE PROCEDURE

K863394 is the FDA 510(k) clearance for RAPID SPECIFIC IGE PROCEDURE by Allertec, Inc.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K863394 · Allertec, Inc. · Immunology device
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Dec 1986
Decision
91d
Days
Class 2
Risk

K863394 is an FDA 510(k) clearance for the RAPID SPECIFIC IGE PROCEDURE. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Allertec, Inc. (San Francisco, US). The FDA issued a Cleared decision on December 3, 1986 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5750 - 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 Allertec, Inc. devices

Submission Details

510(k) Number K863394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1986
Decision Date December 03, 1986
Days to Decision 91 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 104d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHB System, Test, Radioallergosorbent (rast) Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5750
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 - DHB System, Test, Radioallergosorbent (rast) Immunological

All 200
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K863394.
ALLERGEN SPECIFIC IGG4 CONTROL SERA
K870153 · 3M Company · Feb 1987
ALLERGEN SPECIFIC CONTROLS
K870152 · 3M Company · Feb 1987
SPECIFIC IGE FAST(TM) TEST II
K863967 · 3M Company · Dec 1986
3M IGG4 FAST TEST PACKAGE
K863794 · 3M Company · Dec 1986
PHADEBAS RAST/PHADEZYM RAST ALLERTUBE
K863036 · Pharmacia, Inc. · Oct 1986
PHADIOTOP (TM) RIA/PHADIOTOP (TM) EIA
K863355 · Pharmacia, Inc. · Sep 1986