Cleared Traditional

K864104 - ADDITONAL ALLERGENS FOR IGE FAST (TM) TEST

K864104 is the FDA 510(k) clearance for ADDITONAL ALLERGENS FOR IGE FAST (TM) TEST by 3M Company. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K864104 · 3M Company · Immunology device
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Feb 1987
Decision
114d
Days
Class 2
Risk

K864104 is an FDA 510(k) clearance for the ADDITONAL ALLERGENS FOR IGE FAST (TM) TEST. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by 3M Company (Mountain View, US). The FDA issued a Cleared decision on February 12, 1987 after a review of 114 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.

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Submission Details

510(k) Number K864104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1986
Decision Date February 12, 1987
Days to Decision 114 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
10d slower than avg
Panel avg: 104d · This submission: 114d
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 187
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K864104.
VENTREX IP SPECIFIC E ENZYME IMMUNOASSAY
K870624 · Ventrex Laboratories, Inc. · Mar 1987
D. FARINAE ALLERGEN DISC
K870597 · Incstar Corp. · Mar 1987
CAT EPITHELIUM ALLERGEN DISC
K870264 · Incstar Corp. · Feb 1987
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