Cleared Traditional

K897145 - 3M MULTI-ALLERGEN IGE FASTSCREEN S7

K897145 is the FDA 510(k) clearance for 3M MULTI-ALLERGEN IGE FASTSCREEN S7 by 3M Company. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K897145 · 3M Company · Immunology device
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Jan 1990
Decision
14d
Days
Class 2
Risk

K897145 is an FDA 510(k) clearance for the 3M MULTI-ALLERGEN IGE FASTSCREEN S7, (G3,4,5,6,8). 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 January 10, 1990 after a review of 14 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 K897145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1989
Decision Date January 10, 1990
Days to Decision 14 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
90d faster than avg
Panel avg: 104d · This submission: 14d
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 K897145.
ALASTAT ALLERGEN-SPEC IGE CONTROL DC1A/2A/6A/NGCA
K902576 · Diagnostic Products Corp. · Sep 1990
PHARMACIA CAP SYSTEM RAST RIA & RAST FEIA
K894190 · Pharmacia, Inc. · Jan 1990
ENZYMUN TEST R IGE
K896902 · Boehringer Mannheim Corp. · Jan 1990
VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY
K896852 · Ventrex Laboratories, Inc. · Dec 1989
VENTREZYME VAST SPECIFIC IGE ASSAY
K896694 · Ventrex Laboratories, Inc. · Dec 1989
CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY
K896592 · Ciba Corning Diagnostics Corp. · Dec 1989