Cleared Traditional

K875168 - QUIDEL TOTAL IGE TEST

K875168 is an FDA 510(k) clearance for QUIDEL TOTAL IGE TEST, manufactured by Quidel Corp.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K875168

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
12d faster than avg
Panel avg: 105d · This submission: 93d
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 230
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K875168.
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
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
TOTAL IGE IMMUNO RESPONSE TEST (IRT(R))
K875274 · Incstar Corp. · Feb 1988