Product Classification

• Device: allergen and vaccine delivery needles
• Regulation Description: Hypodermic single lumen needle.
• 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.
• Physical State: The device may be a single needle or an array of multiple needles.
• Technical Method: The needles may be used to scratch or prick the skin during an allergy test or may be used for an intradermal injection of an allergenic extract.
• Target Area: The device is used on or through the skin typically on the forearm, upper arm, or back of the patient.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: SCL
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
• Submission Type: 510(k)
• Regulation Number: 880.5570
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• aabb
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc