Cleared Traditional

K875168 - QUIDEL TOTAL IGE TEST

K875168 is the FDA 510(k) clearance for QUIDEL TOTAL IGE TEST by Quidel Corp.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K875168 · Quidel Corp. · Immunology device
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Mar 1988
Decision
93d
Days
Class 2
Risk

K875168 is an FDA 510(k) clearance for the QUIDEL TOTAL IGE TEST. 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 March 18, 1988 after a review of 93 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 K875168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1987
Decision Date March 18, 1988
Days to Decision 93 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
11d faster than avg
Panel avg: 104d · This submission: 93d
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 K875168.
DPC'S ALLERGEN-SPECIFIC IGE SYSTEM
K880160 · Diagnostic Products Corp. · Apr 1988
QUIDEL ALLERGY SCREEN
K874717 · Quidel Corp. · Apr 1988
VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY
K880547 · Ventrex Laboratories, Inc. · Mar 1988
ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST
K880003 · Em Diagnostic Systems, Inc. · Mar 1988
MULTI-ALLERGEN IGE FAST SCREEN III D1,E1,G6,M2,T3
K880001 · 3M Company · Feb 1988
MULTI-ALLERGEN IGE FAST SCREEN (MOLDS)
K880002 · 3M Company · Feb 1988