DEN200059 is an FDA 510(k) submission for the POMC/PCSK1/LEPR CDx Panel. This device is classified as a Setmelanotide Eligibility Gene Variant Detection System (Class II - Special Controls, product code QRV).
Submitted by Preventiongenetics, LLC (Marshfield, US). The FDA issued a Not Cleared (DENG) decision on January 21, 2022.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1164. A Setmelanotide Eligibility Gene Variant Detection System Is A Qualitative In Vitro Diagnostic Device Intended To Detect Germline Variants Within Genes Isolated From Human Specimens For The Purpose Of Identifying Patients With Obesity Who May Benefit From Treatment With Setmelanotide In Accordance With The Approved Therapeutic Product Labeling..
| 510(k) Number | DEN200059 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 18, 2020 |
| Decision Date | January 21, 2022 |
| Days to Decision | 490 days |
| Submission Type | Direct |
| Review Panel | Chemistry (CH) |
| Summary | - |
| Product Code | QRV - Setmelanotide Eligibility Gene Variant Detection System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1164 |
| Definition | A Setmelanotide Eligibility Gene Variant Detection System Is A Qualitative In Vitro Diagnostic Device Intended To Detect Germline Variants Within Genes Isolated From Human Specimens For The Purpose Of Identifying Patients With Obesity Who May Benefit From Treatment With Setmelanotide In Accordance With The Approved Therapeutic Product Labeling. |