Product Classification

• Device: ige, antigen, antiserum, control
• Regulation Description: Immunoglobulins A, G, M, D, and E immunological test system.
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Product Code: DGC
• Submission Type: 510(k)
• Regulation Number: 866.5510
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• CLSI I/LA20-A2 Analytical Performance Characteristics and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities; Approved Guideline - Second Edition

Guidance Document

• Draft Guidance Document for 510(k) Submission of Immunoglobulins A,G,M,D and E Immunoglobulin System In Vitro Devices  

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.