Product Code: SCL FDA class 2 21 CFR 880.5570

Allergen And Vaccine Delivery Needles

General Hospital

Allergen and vaccine delivery needles are devices intended to percutaneously deliver diagnostic allergenic extracts for use in allergy skin tests (skin prick tests or intradermal allergy tests), enabling standardized allergen delivery for accurate diagnosis of allergic conditions. They are classified as FDA Class II (510(k) required) under regulation 880.5570 in the General Hospital specialty, with product code SCL; they are eligible for third-party review. The device is not an implant and does not support life-sustaining functions.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: SCL
Device Class: FDA class 2
Regulation Number: 880.5570
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

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.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 25 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250983	Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)	Jan 30, 2026	Substantially Equivalent	Asistan Medikal
K222385	Bifurcated Needle	Dec 06, 2022	Substantially Equivalent	Anhui Tiankang Medical Technology Co., Ltd.
K182582	Oryum and Ovem Epidermal Deri Prick Test Applicator	Apr 10, 2019	Substantially Equivalent	Allergy & Applicator Depot, LLC
K172062	AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray	Mar 05, 2018	Substantially Equivalent	Medscience Science Research Group, Inc.
K162917	Allerhope Allergy Skin Tester	Aug 17, 2017	Substantially Equivalent	Procare Industrial Co., Limited
K032528	BD ECLIPSE BIFURCATED NEEDLE	Sep 09, 2003	Substantially Equivalent	Becton, Dickinson & CO
K031630	BIFURCATED ALLERGY SKIN TESTING NEEDLE	Aug 07, 2003	Substantially Equivalent	Precision Medical Products, Inc.
K020523	BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757	Mar 20, 2002	Substantially Equivalent	Bd
K020500	UNIVEC BIFURCATED SLIDING SHEATH SYRINGE	Mar 19, 2002	Substantially Equivalent	Univec, Inc.
K012515	BIFURCATED VACCINATING NEEDLE	Sep 19, 2001	Substantially Equivalent	Precision Medical Products, Inc.
K011979	ALLERSHARP ALLERGY SKIN TESTER	Sep 14, 2001	Substantially Equivalent	Hmb Medical Concepts, Ltd.
K003195	GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC	Dec 13, 2000	Substantially Equivalent	Greer Laboratories, Inc.
K000299	DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D	Apr 28, 2000	Substantially Equivalent	Biomedex, Inc.
K982578	QUANTI-TEST SYSTEM	Sep 02, 1998	Substantially Equivalent	Panatrex, Inc.
K961918	MULTI-TEST II	Aug 07, 1996	Substantially Equivalent	Lincoln Diagnostics, Inc.
K953939	QUINTEST	Nov 13, 1995	Substantially Equivalent	Bayer Corp.
K941820	DUOTIP-TEST	Sep 02, 1994	Substantially Equivalent	Lincoln Diagnostics, Inc.
K922177	DISPOSABLE MULTI-PUNCTURE APPLICATOR	Jun 17, 1993	Substantially Equivalent	Allergy Extract Co.
K890360	GREER DERMAPIK SYSTEM	Jun 23, 1989	Substantially Equivalent	Greer Laboratories, Inc.
K882360	DERMAPIK	Aug 09, 1988	Substantially Equivalent	Creative Scientific Equipment Corp.
K844221	HMB ALLERGOGEN SKIN PRICK TEST NEEDLE	Feb 08, 1985	Substantially Equivalent	Aller/Guard, Inc.
K842107	COMBO SKIN TEST READY TO USE TAPE	Sep 05, 1984	Substantially Equivalent	Combion Systems, Inc.
K833999	COMBION SKIN TEST - FOUR PRONG	Sep 05, 1984	Substantially Equivalent	Nicholas H. Maganias
K791328	ALLER-SCREEN SKIN TEST KIT	May 30, 1980	Substantially Equivalent	Aller-Screen, Inc.
K760699	MULTI-TEST	Dec 30, 1976	Substantially Equivalent	Lincoln Laboratories, Inc.