Cleared Traditional

K883371 - MULTI-ALLERGEN IGE FASTSCREEN V (T1

K883371 is the FDA 510(k) clearance for MULTI-ALLERGEN IGE FASTSCREEN V (T1 by 3M Company. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K883371 · 3M Company · Immunology device
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Oct 1988
Decision
78d
Days
Class 2
Risk

K883371 is an FDA 510(k) clearance for the MULTI-ALLERGEN IGE FASTSCREEN V (T1,T3,T5,T7,T10). 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 October 27, 1988 after a review of 78 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.

View all 3M Company devices

Submission Details

510(k) Number K883371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1988
Decision Date October 27, 1988
Days to Decision 78 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
26d faster than avg
Panel avg: 104d · This submission: 78d
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 K883371.
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QUIDEL ALLERGY SCREEN
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SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM)
K883616 · Diagnostic Products Corp. · Sep 1988