Cleared Traditional

K880002 - MULTI-ALLERGEN IGE FAST SCREEN (MOLDS)

K880002 is an FDA 510(k) clearance for MULTI-ALLERGEN IGE FAST SCREEN (MOLDS), 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 44-day FDA review.

K880002 · 3M Company · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1988
Decision
44d
Days
Class 2
Risk

K880002 is an FDA 510(k) clearance for the MULTI-ALLERGEN IGE FAST SCREEN (MOLDS). 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 February 17, 1988 after a review of 44 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

FDA 510(k) Submission Details - K880002

510(k) Number K880002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1988
Decision Date February 17, 1988
Days to Decision 44 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
61d faster than avg
Panel avg: 105d · This submission: 44d
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 231
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K880002.
ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST
K880003 · Em Diagnostic Systems, Inc. · Mar 1988
MULTI-ALLERGEN IGE FAST SCREEN III D1,E1,G6,M2,T3
K880001 · 3M Company · Feb 1988
TOTAL IGE IMMUNO RESPONSE TEST (IRT(R))
K875274 · Incstar Corp. · Feb 1988
MULTI-ALLERGEN IGE FAST SCREEN (ENVIRONMENTAL)
K874446 · 3M Company · Dec 1987
MEDIX BIOTECH IGE VISUAL SCREENING TEST KIT
K874281 · Medix Biotech, Inc. · Dec 1987
LIVE OAK ALLERGEN DISC
K874440 · Incstar Corp. · Nov 1987