Product Classification

• Device: antinuclear antibody, antigen, control
• Regulation Description: Antinuclear antibody immunological test system.
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Product Code: LKJ
• Submission Type: 510(k)
• Regulation Number: 866.5100
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• CLSI I/LA2-A2 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 Accredited Persons Program

Accredited Persons

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