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U.S. Department of Health and Human Services

Product Classification

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Device anti-ss-a ro60 autoantibodies
Regulation Description Antinuclear antibody immunological test system.
Definition Ro60 assays are designed for the determination of IgG anti-Ro60 (SS-A Ro60) autoantibodies in human serum. The presence of anti-Ro60 autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus and Sjögren's Syndrome.
Physical State 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 CodePET
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons