Cleared Traditional

ALLER-SCREEN SKIN TEST KIT (K791328) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K791328 · Aller-Screen, Inc. · General Hospital
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May 1980
Decision
323d
Days
Class 2
Risk

K791328 is an FDA 510(k) clearance for the ALLER-SCREEN SKIN TEST KIT. Classified as Allergen And Vaccine Delivery Needles (product code SCL), Class II - Special Controls.

Submitted by Aller-Screen, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 30, 1980 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Aller-Screen, Inc. devices

Submission Details

510(k) Number K791328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1979
Decision Date May 30, 1980
Days to Decision 323 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 129d · This submission: 323d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SCL Allergen And Vaccine Delivery Needles
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
Definition An Allergen Delivery Needle Is A Device Intended To Percutaneously Deliver Diagnostic Allergenic Extracts For Use In Allergy Skin Tests Also Referred To As Skin Prick Tests Or Intradermal Allergy Tests.
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 General Hospital devices follow this clearance model.

Regulatory Peers - SCL Allergen And Vaccine Delivery Needles

Devices cleared under the same product code (SCL) and FDA review panel - the closest regulatory comparables to K791328.
Oryum and Ovem Epidermal Deri Prick Test Applicator
K182582 · Allergy & Applicator Depot, LLC · Apr 2019
AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray
K172062 · Medscience Science Research Group, Inc. · Mar 2018
BD ECLIPSE BIFURCATED NEEDLE
K032528 · Becton, Dickinson & CO · Sep 2003