K193081 is an FDA 510(k) clearance for the Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit. This device is classified as a Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections (Class II - Special Controls, product code QEP).
Submitted by Rheonix, Inc. (Ithaca, US). The FDA issued a Cleared decision on December 17, 2021, 773 days after receiving the submission on November 5, 2019.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3393. A Device To Detect Nucleic Acids From Non-viral Microorganism(s) Causing Sexually Transmitted Infections Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Nucleic Acids From Non-viral Microorganism(s) In Clinical Specimens Collected From Patients Suspected Of Sexually Transmitted Infections. The Device Is Intended To Aid In The Diagnosis Of Non-viral Sexually Transmitted Infections In Conjunction With Other Clinical And Laboratory Data..
| 510(k) Number | K193081 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2019 |
| Decision Date | December 17, 2021 |
| Days to Decision | 773 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | QEP - Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3393 |
| Definition | A Device To Detect Nucleic Acids From Non-viral Microorganism(s) Causing Sexually Transmitted Infections Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Nucleic Acids From Non-viral Microorganism(s) In Clinical Specimens Collected From Patients Suspected Of Sexually Transmitted Infections. The Device Is Intended To Aid In The Diagnosis Of Non-viral Sexually Transmitted Infections In Conjunction With Other Clinical And Laboratory Data. |