Anti-Ss-A 52 Autoantibodies
FDA product code OBE · Class II (moderate risk) · 21 CFR 866.5100 · Immunology
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.
3510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250814 | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSBOBE · Traditional | Zeus Scientific | 05/08/2026SE |
| K141655 | Quanta Flash RO52, Quanta Flash RO52 Calibrators, and Quanta Flash RO52 ControlsOBE · Traditional | Inova Diagnostics, Inc. | 03/05/2015SE |
| K063565 | Quanta Lite Ss-A 52 ElisaOBE · Traditional | Inova Diagnostics, Inc. | 04/04/2007SE |