Cleared Traditional

K874168 - IVT SOUTHEAST ALLERGY SCREEN

K874168 is the FDA 510(k) clearance for IVT SOUTHEAST ALLERGY SCREEN by In Vitro Technologies, Inc.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K874168 · In Vitro Technologies, Inc. · Immunology device
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Jan 1988
Decision
90d
Days
Class 2
Risk

K874168 is an FDA 510(k) clearance for the IVT SOUTHEAST ALLERGY SCREEN. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by In Vitro Technologies, Inc. (Arlington, US). The FDA issued a Cleared decision on January 11, 1988 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all In Vitro Technologies, Inc. devices

Submission Details

510(k) Number K874168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1987
Decision Date January 11, 1988
Days to Decision 90 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 104d · This submission: 90d
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 200
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K874168.
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 (MOLDS)
K880002 · 3M Company · 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