K050662 is an FDA 510(k) clearance for the QUANTA LITE SP100 ELISA. This device is classified as a Autoantibodies, Nuclear Body Protein, Sp100 (Class II - Special Controls, product code NUM).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on June 13, 2005, 90 days after receiving the submission on March 15, 2005.
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 Sp100 (nuclear Body Protein Sp100) As An Aid In The Diagnosis Of Primary Biliary Cirrhosis..
| 510(k) Number | K050662 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 2005 |
| Decision Date | June 13, 2005 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | NUM — Autoantibodies, Nuclear Body Protein, Sp100 |
| 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 Sp100 (nuclear Body Protein Sp100) As An Aid In The Diagnosis Of Primary Biliary Cirrhosis. |