Cleared Traditional

K884501 - QUIDEL FOOD ALLERGY SCREEN

K884501 is an FDA 510(k) clearance for QUIDEL FOOD ALLERGY SCREEN, 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 114-day FDA review.

K884501 · Quidel Corp. · Immunology device
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Feb 1989
Decision
114d
Days
Class 2
Risk

K884501 is an FDA 510(k) clearance for the QUIDEL FOOD ALLERGY SCREEN. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on February 17, 1989 after a review of 114 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 - K884501

510(k) Number K884501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1988
Decision Date February 17, 1989
Days to Decision 114 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
9d slower than avg
Panel avg: 105d · This submission: 114d
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 K884501.
PHADEBAS RAST(R)/PHADEZYM(R) RAST ALLERGEN DISC
K893132 · Pharmacia, Inc. · Jun 1989
PHADIATOP PAEDIATRIC RIA AND EIA
K891135 · Pharmacia, Inc. · May 1989
QUIDEL FOOD ALLERGEN SCREEN - BARLEY ALLERGEN
K892409 · Quidel Corp. · May 1989
28 ADDITIONAL ALLERGEN MODULES FOR ALASTAT(TM)
K884883 · Diagnostic Products Corp. · Jan 1989
MIXED ALLERGEN PANEL MODULES FOR ALASTAT(TM)
K884923 · Diagnostic Products Corp. · Jan 1989
IGE FASTSCREEN S6 (F1, F2, F4, F13, F14)
K885065 · 3M Company · Jan 1989