Anti-Ss-A 52 Autoantibodies
The Anti-SS-A 52 Autoantibodies device (product code OBE) is an in vitro diagnostic test used for the detection of autoantibodies to SS-A 52 in human serum or plasma, with detection aiding in the diagnosis of systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, polymyositis, and dermatomyositis. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 866.5100 within the Immunology specialty. Third-party 510(k) review is available, and the device carries no implant or life-sustaining flags.
Research product code OBE in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- OBE
- Device Class
- FDA class 2
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250814 | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB | May 08, 2026 | Substantially Equivalent | Zeus Scientific |
| K141655 | QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS | Mar 05, 2015 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K063565 | QUANTA LITE SS-A 52 ELISA | Apr 04, 2007 | Substantially Equivalent | Inova Diagnostics, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.