K202541 is an FDA 510(k) clearance for the EliA RNA Pol III. This device is classified as a Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody (Class II - Special Controls, product code NYO).
Submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on September 13, 2021, 376 days after receiving the submission on September 2, 2020.
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 | K202541 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 2020 |
| Decision Date | September 13, 2021 |
| Days to Decision | 376 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| 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. |