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U.S. Department of Health and Human Services

Product Classification

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Device anti-ss-a 52 autoantibodies
Regulation Description Antinuclear antibody immunological test system.
Definition The device is used for the detection, in human serum or plasma, of autoantibodies to ss-a 52.The detection of ss-a 52 autoantibodies may aid in the diagnosis of systemic lupus erythematosus, sjogren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.
Physical State The device consist of components/reagents to detect and semi-quantitatively measure autoantibodies to SS-A 52.
Technical Method Enzyme-linked immunosorbent assay (ELISA) or enzyme immunoassay (EIA)
Target Area The assay is performed by testing human serum or plasma.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeOBE
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5100
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff: Recommendations for Anti-Nuclear Antibody (ANA) Test System Premarket (510(k)) Submissions [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm092748.htm] 
Third Party Review Not Third Party Eligible
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