510(k) K193081
K193081 is an FDA 510(k) premarket notification submitted by Rheonix, Inc. for the device "Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit". The FDA issued a decision of Substantially Equivalent on December 17, 2021. The device falls under product code QEP (Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections), a Class II device regulated under 21 CFR 866.3393.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 2021
- Date Received
- November 5, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
- Device Class
- Class II
- Regulation Number
- 866.3393
- Review Panel
- MI
- Submission Type
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.