Cleared Traditional

K873998 - TOTAL IGE FAST (TM) TEST PACKAGE

K873998 is the FDA 510(k) clearance for TOTAL IGE FAST (TM) TEST PACKAGE by 3M Company. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K873998 · 3M Company · Immunology device
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Nov 1987
Decision
34d
Days
Class 2
Risk

K873998 is an FDA 510(k) clearance for the TOTAL IGE FAST (TM) TEST PACKAGE. 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 November 4, 1987 after a review of 34 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 K873998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1987
Decision Date November 04, 1987
Days to Decision 34 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
70d faster than avg
Panel avg: 104d · This submission: 34d
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 K873998.
MEDIX BIOTECH IGE VISUAL SCREENING TEST KIT
K874281 · Medix Biotech, Inc. · Dec 1987
LIVE OAK ALLERGEN DISC
K874440 · Incstar Corp. · Nov 1987
GIANT RAGWEED ALLERGEN DISC
K873969 · Incstar Corp. · Nov 1987
FALSE RAGWEED ALLERGEN DISC
K874149 · Incstar Corp. · Nov 1987
JOHNSON GRASS ALLERGEN DISC
K874150 · Incstar Corp. · Nov 1987
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC
K872946 · Pharmacia, Inc. · Oct 1987