510(k) K061842
K061842 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA LITE PBC SCREEN IGG/IGA ELISA". The FDA issued a decision of Substantially Equivalent on October 18, 2006. The device falls under product code NRI (Autoantibodies, Nuclear Pore Glycoprotein Gp210), a Class II device regulated under 21 CFR 866.5090. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2006
- Date Received
- June 29, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Autoantibodies, Nuclear Pore Glycoprotein Gp210
- Device Class
- Class II
- Regulation Number
- 866.5090
- Review Panel
- IM
- Submission Type
The device is used for the detection, in human serum or plasma, of autoantibodies to gp210 (nuclear pore glycoprotein gp210) as an aid in the diagnosis of primary biliary cirrhosis.