510(k) K250814
K250814 is an FDA 510(k) premarket notification submitted by Zeus Scientific for the device "Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB". The FDA issued a decision of Substantially Equivalent on May 8, 2026. The device falls under product code OBE (Anti-Ss-A 52 Autoantibodies), a Class II device regulated under 21 CFR 866.5100. Zeus Scientific has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 2026
- Date Received
- March 17, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anti-Ss-A 52 Autoantibodies
- Device Class
- Class II
- Regulation Number
- 866.5100
- Review Panel
- IM
- Submission Type
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.