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 Code | PET |
Premarket Review |
Division of Immunology and Hematology Devices
(DIHD)
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
|
Third Party Review
|
Accredited Persons
|