Cleared Traditional

K874717 - QUIDEL ALLERGY SCREEN

K874717 is the FDA 510(k) clearance for QUIDEL ALLERGY SCREEN by Quidel Corp.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K874717 · Quidel Corp. · Immunology device
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Apr 1988
Decision
141d
Days
Class 2
Risk

K874717 is an FDA 510(k) clearance for the QUIDEL ALLERGY SCREEN. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Quidel Corp. (La Jolla, US). The FDA issued a Cleared decision on April 6, 1988 after a review of 141 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 Quidel Corp. devices

Submission Details

510(k) Number K874717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1987
Decision Date April 06, 1988
Days to Decision 141 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
37d slower than avg
Panel avg: 104d · This submission: 141d
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 146
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K874717.
PHARMACIA IGG RAST RIA/PHARMACIA IGG RAST EIA
K880899 · Pharmacia, Inc. · May 1988
ALLEIA (TM) ALLERGEN SPECIFIC IGE SYSTEM
K875244 · Diagnostic Products Corp. · Apr 1988
DPC'S ALLERGEN-SPECIFIC IGE SYSTEM
K880160 · Diagnostic Products Corp. · Apr 1988
VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY
K880547 · Ventrex Laboratories, Inc. · Mar 1988
QUIDEL TOTAL IGE TEST
K875168 · Quidel Corp. · Mar 1988
ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST
K880003 · Em Diagnostic Systems, Inc. · Mar 1988