K061842 is an FDA 510(k) clearance for the QUANTA LITE PBC SCREEN IGG/IGA ELISA. This device is classified as a Autoantibodies, Nuclear Pore Glycoprotein Gp210 (Class II - Special Controls, product code NRI).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on October 18, 2006, 111 days after receiving the submission on June 29, 2006.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5090. 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..
| 510(k) Number | K061842 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2006 |
| Decision Date | October 18, 2006 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | NRI — Autoantibodies, Nuclear Pore Glycoprotein Gp210 |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5090 |
| Definition | 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. |