Product Classification

• Device: antinuclear antibody, indirect immunofluorescent, antigen, control
• Regulation Description: Antinuclear antibody immunological test system.
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Product Code: DHN
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(k)
• Regulation Number: 866.5100
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 7-136 CLSI I/LA2-A2 (Replaces I/LA2-A)
  Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Flurescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline - Second Edition.

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc