# K193081: Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Rheonix, Inc.
- Decided: Dec 17, 2021 after 773 days
- Product code: QEP (Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections)
- Device class: 2
- Regulation: 21 CFR 866.3393
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K984631 (1999). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182692: BD MAX CTGCTV2, BD MAX System, Becton, Dickinson and Company (2019) Summary page 5.

## Indications for use
For In Vitro Diagnostic Use. The Rheonix STI TriPlex™ Assay, as performed on the Rheonix Encompass MDx® Workstation, is an automated DNA extraction and multiplex PCR amplification test system intended for the direct, qualitative detection of DNA from Chlamydia trachomatis (CT), and/or Neisseria gonorrhoeae (NG), and/or Trichomonas vaginalis (TV) in male urine specimens collected with the Rheonix Urine Specimen Collection Kit. The test is indicated to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and trichomoniasis in asymptomatic or symptomatic male individuals.

Source page: https://510kreport.com/device/K193081
Methodology: https://510kreport.com/methodology