Cleared Traditional

K884501 - QUIDEL FOOD ALLERGY SCREEN

K884501 is the FDA 510(k) clearance for QUIDEL FOOD ALLERGY SCREEN by Quidel Corp.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K884501 · Quidel Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
10d slower than avg
Panel avg: 104d · This submission: 114d
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 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