K063565 is an FDA 510(k) clearance for the QUANTA LITE SS-A 52 ELISA. This device is classified as a Anti-ss-a 52 Autoantibodies (Class II - Special Controls, product code OBE).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on April 4, 2007, 127 days after receiving the submission on November 28, 2006.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100. 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..
| 510(k) Number | K063565 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 2006 |
| Decision Date | April 04, 2007 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | OBE — Anti-ss-a 52 Autoantibodies |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |
| Definition | 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. |