510(k) K063565
K063565 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA LITE SS-A 52 ELISA". The FDA issued a decision of Substantially Equivalent on April 4, 2007. The device falls under product code OBE (Anti-Ss-A 52 Autoantibodies), a Class II device regulated under 21 CFR 866.5100. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 2007
- Date Received
- November 28, 2006
- 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.