DEN200070 is an FDA 510(k) submission for the Simple 2 Test. This device is classified as a System For Detection Of Nucleic Acid From Non-viral Microorganism(s) Causing Stis Using Specimens Collected At Home (Class II - Special Controls, product code QYA).
Submitted by Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) (Dun Laoghaire, IE). The FDA issued a Not Cleared (DENG) decision on November 15, 2023.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3385. This Device Is An In Vitro Diagnostic System Intended For Self-collecting Specimens In Home Settings Or Similar Environments And Testing In A Clinical Laboratory For Detection Of Nucleic Acids From Non-viral Microorganism(s) Causing Sexually Transmitted Infections. The Device Is Intended To Aid In The Diagnosis Of Sexually Transmitted Infections. The Device Is Intended For Prescription Use Or Over-the-counter Use..
| 510(k) Number | DEN200070 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | November 16, 2020 |
| Decision Date | November 15, 2023 |
| Days to Decision | 1094 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | - |
| Product Code | QYA - System For Detection Of Nucleic Acid From Non-viral Microorganism(s) Causing Stis Using Specimens Collected At Home |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3385 |
| Definition | This Device Is An In Vitro Diagnostic System Intended For Self-collecting Specimens In Home Settings Or Similar Environments And Testing In A Clinical Laboratory For Detection Of Nucleic Acids From Non-viral Microorganism(s) Causing Sexually Transmitted Infections. The Device Is Intended To Aid In The Diagnosis Of Sexually Transmitted Infections. The Device Is Intended For Prescription Use Or Over-the-counter Use. |