Cleared Traditional

K874446 - MULTI-ALLERGEN IGE FAST SCREEN (ENVIRONMENTAL)

K874446 is an FDA 510(k) clearance for MULTI-ALLERGEN IGE FAST SCREEN (ENVIRON..., manufactured by 3M Company. The device is a Class 2 Immunology device with product code DHB cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K874446 · 3M Company · Immunology device
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Dec 1987
Decision
63d
Days
Class 2
Risk

K874446 is an FDA 510(k) clearance for the MULTI-ALLERGEN IGE FAST SCREEN (ENVIRONMENTAL). Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by 3M Company (Santa Clara, US). The FDA issued a Cleared decision on December 30, 1987 after a review of 63 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K874446

510(k) Number K874446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1987
Decision Date December 30, 1987
Days to Decision 63 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
42d faster than avg
Panel avg: 105d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHB Device Classification - Class 2, Special Controls

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 268
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K874446.
ADDITIONAL ALLERGENS FOR ALLERG*ENS EIA KIT
K875066 · Dexall Biomedical Labs, Inc. · Jan 1988
IVT SOUTHEAST ALLERGY SCREEN
K874168 · In Vitro Technologies, Inc. · Jan 1988
IVT NORTHEAST ALLERGY SCREEN
K874169 · In Vitro Technologies, Inc. · Jan 1988
MEDIX BIOTECH IGE VISUAL SCREENING TEST KIT
K874281 · Medix Biotech, Inc. · Dec 1987
LIVE OAK ALLERGEN DISC
K874440 · Incstar Corp. · Nov 1987
GIANT RAGWEED ALLERGEN DISC
K873969 · Incstar Corp. · Nov 1987
K874446 · MULTI-ALLERGEN IGE FAST SCREEN (ENVIRONMENTAL)
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