Cleared Traditional

K950728 - QUICKVUE ONE-STEP ALLERGEN SCREEN

K950728 is an FDA 510(k) clearance for QUICKVUE ONE-STEP ALLERGEN 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 228-day FDA review.

K950728 · Quidel Corp. · Immunology device
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Oct 1995
Decision
228d
Days
Class 2
Risk

K950728 is an FDA 510(k) clearance for the QUICKVUE ONE-STEP ALLERGEN 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 October 2, 1995 after a review of 228 days - an extended review cycle.

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 - K950728

510(k) Number K950728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1995
Decision Date October 02, 1995
Days to Decision 228 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 105d · This submission: 228d
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 K950728.
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K945884 · Hycor Biomedical, Inc. · Jun 1995
HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY
K945748 · Hycor Biomedical, Inc. · Jun 1995