OBE — Anti-Ss-A 52 Autoantibodies Class II
Classification Details
- Product Code
- OBE
- Device Class
- Class II
- Regulation Number
- 866.5100
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250814 | zeus scientific | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB | May 8, 2026 |
| K141655 | inova diagnostics | QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS | March 5, 2015 |
| K063565 | inova diagnostics | QUANTA LITE SS-A 52 ELISA | April 4, 2007 |