Cleared Traditional

K874168 - IVT SOUTHEAST ALLERGY SCREEN

K874168 is an FDA 510(k) clearance for IVT SOUTHEAST ALLERGY SCREEN, manufactured by In Vitro Technologies, Inc.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K874168

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
15d faster than avg
Panel avg: 105d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHB Device Classification - Class 2, Special Controls

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 232
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