K040885 is an FDA 510(k) clearance for the QUANTA LITE GP210 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 June 25, 2004, 81 days after receiving the submission on April 5, 2004.
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 | K040885 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2004 |
| Decision Date | June 25, 2004 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| 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. |