K243410 is an FDA 510(k) clearance for the simpli-COLLECT STI 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 Abbott Molecular (Des Plaines, US). The FDA issued a Cleared decision on January 30, 2025, 90 days after receiving the submission on November 1, 2024.
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 | K243410 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2024 |
| Decision Date | January 30, 2025 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| 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. |