K141655 is an FDA 510(k) clearance for the QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS. 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 March 5, 2015, 258 days after receiving the submission on June 20, 2014.
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 | K141655 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2014 |
| Decision Date | March 05, 2015 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| 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. |