Cleared Traditional

K875329 - IVT CENTRAL ALLERGY SCREEN

K875329 is the FDA 510(k) clearance for IVT CENTRAL 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 99-day FDA review.

K875329 · In Vitro Technologies, Inc. · Immunology device
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Apr 1988
Decision
99d
Days
Class 2
Risk

K875329 is an FDA 510(k) clearance for the IVT CENTRAL 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 April 7, 1988 after a review of 99 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 K875329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1987
Decision Date April 07, 1988
Days to Decision 99 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 104d · This submission: 99d
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 K875329.
INCSTAR'S DANDELION ALLERGEN DISC
K880187 · Incstar Corp. · Apr 1988
MESQUITE ALLERGEN DISC
K880415 · Incstar Corp. · Apr 1988
WHITE ASH ALLERGEN DISC
K880567 · Incstar Corp. · Apr 1988
QUIDEL ALLERGY SCREEN
K874717 · Quidel Corp. · Apr 1988
VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY
K880547 · Ventrex Laboratories, Inc. · Mar 1988
QUIDEL TOTAL IGE TEST
K875168 · Quidel Corp. · Mar 1988