K070066 is an FDA 510(k) clearance for the QUANTA LITE RNA POL III ELISA. This device is classified as a Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody (Class II - Special Controls, product code NYO).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on April 11, 2007, 93 days after receiving the submission on January 8, 2007.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100. The Anti-rna Polymerase Iii Test Is A Semi-quantitative Elisa For The Detection Of Anti-rna Polymerase Iii Antibodies In Human Serum. The Test Result Is Used As An Aid In The Diagnosis Of Systemic Sclerosis (ssc) In Conjunction With The Clinical And Other Laboratory Findings. For In-vitro Diagnostic Use..
| 510(k) Number | K070066 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 08, 2007 |
| Decision Date | April 11, 2007 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | NYO — Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |
| Definition | The Anti-rna Polymerase Iii Test Is A Semi-quantitative Elisa For The Detection Of Anti-rna Polymerase Iii Antibodies In Human Serum. The Test Result Is Used As An Aid In The Diagnosis Of Systemic Sclerosis (ssc) In Conjunction With The Clinical And Other Laboratory Findings. For In-vitro Diagnostic Use. |