Cleared Traditional

K883273 - DHBTI-ALLERGEN IGE FASTSCREEN IV (G1

K883273 is the FDA 510(k) clearance for DHBTI-ALLERGEN IGE FASTSCREEN IV (G1 by 3M Company. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K883273 · 3M Company · Immunology device
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Sep 1988
Decision
35d
Days
Class 2
Risk

K883273 is an FDA 510(k) clearance for the DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13). 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 September 7, 1988 after a review of 35 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 K883273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1988
Decision Date September 07, 1988
Days to Decision 35 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
69d faster than avg
Panel avg: 104d · This submission: 35d
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 K883273.
CIBA CORNING MAGIC LITE TOTAL IGE IMMUNOASSAY
K884185 · Ciba Corning Diagnostics Corp. · Oct 1988
QUIDEL ALLERGY SCREEN
K883666 · Quidel Corp. · Oct 1988
SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM)
K883616 · Diagnostic Products Corp. · Sep 1988
SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) IGE SYS.
K881899 · Diagnostic Products Corp. · Aug 1988
HOUSE DUST
K875110 · Incstar Corp. · Jun 1988
PHARMACIA IGG RAST RIA/PHARMACIA IGG RAST EIA
K880899 · Pharmacia, Inc. · May 1988