Cleared Traditional

K900108 - 3M MULTI-ALLER. IGE FASTSCREEN S9 W1

K900108 is the FDA 510(k) clearance for 3M MULTI-ALLER. IGE FASTSCREEN S9 W1 by 3M Company. It is a Class 2 Immunology device (product code DGC) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K900108 · 3M Company · Immunology device
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Feb 1990
Decision
43d
Days
Class 2
Risk

K900108 is an FDA 510(k) clearance for the 3M MULTI-ALLER. IGE FASTSCREEN S9 W1,6,9,10,11,12. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by 3M Company (Santa Clara, US). The FDA issued a Cleared decision on February 21, 1990 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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 K900108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1990
Decision Date February 21, 1990
Days to Decision 43 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: 104d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DGC Ige, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - DGC Ige, Antigen, Antiserum, Control

All 81
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K900108.
POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK
K910082 · Quidel Corp. · Mar 1991
VENTREX COATED TUBE IGE RADIOIMMUNOASSAY
K905612 · Ventrex Laboratories, Inc. · Feb 1991
QUIDEL ALLERGEN SCREEN POSITIVE CONTROL
K903738 · Quidel Corp. · Oct 1990
3M MULTI-ALLERGEN IGE FASTSCREEN(TM) S8
K900244 · 3M Company · Feb 1990
ABBOTT IMX IGE
K895914 · Abbott Laboratories · Nov 1989
MILENIA(TM) TOTAL IGE (MKIE1,5)
K895004 · Diagnostic Products Corp. · Sep 1989