510(k) · Cleared
ClearedRheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rheonix, Inc. · QEP Nucleic Acid Detection System For Non-Viral Microorganism (S) Causing Sexually Transmitted Infections
Cleared on Dec 17, 2021 as substantially equivalent to K182692 (Becton, Dickinson and Company, 2019) after a 773-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Dec 17, 2021
- Review
- 773 days
- Class
- Class II
- Product code
- QEP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K984631 (1999). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK984631 Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae…Becton Dickinson Microbiology Systems · 1999 · Recalled
- 3 generations backK081824 BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssayBecton, Dickinson & CO · 2008
- 2 generations backK151589 BD Max CT/GC/TV, BD Max InstrumentBecton, Dickinson and Company · 2016 · Recalled
- 1 generation backK182692 BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company · 2019
- This deviceK193081 Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation…Rheonix, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K984631 | Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae Amplified Dna… | Becton Dickinson Microbiology Systems | 1999 | 2 |
| −3 | K081824 | BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay | Becton, Dickinson & CO | 2008 | — |
| −2 | K151589 | BD Max CT/GC/TV, BD Max Instrument | Becton, Dickinson and Company | 2016 | 2 |
| −1 | K182692 | BD MAX CTGCTV2, BD MAX System | Becton, Dickinson and Company | 2019 | — |
| 0 (this device) | K193081 | Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and… | Rheonix, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QEP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QEP device
- #1 K260917 cobas CT/NG for use on the cobas…score 13.7 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K182692 | BD MAX CTGCTV2, BD MAX SystemSummary page 5…ssay on Rheonix Encompass MDx® Workstation F. IDENTIFICATION OF LEGALLY MARKETED PREDICATE DEVICE BD MAX CTGCTV2 (assay) and BD MAX™ System (instrument) 510(k) Number: K182692 G. REGULATORY INFORMATION 1. REGULATION SECTION: 21 CFR 866.3393 – Nucleic acid detection system for non-viral microorganism… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- 4 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K182692.
How does its category compare?
All QEP devicesQEP Nucleic Acid Detection System For Non-Viral Microorganism (S) Causing Sexually Transmitted Infections: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QEP
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEP
268in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEP
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QEP
9in 2025
MAUDE reports naming product code QEP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 5 | 85 | 0 | 0 |
| 2020 | 3 | 46 | 0 | 0 |
| 2021 | 3 | 521 | 0 | 1 |
| 2022 | 3 | 438 | 0 | 1 |
| 2023 | 3 | 325 | 0 | 8 |
| 2024 | 0 | — | 3 | 8 |
| 2025 | 4 | 268 | 0 | 9 |
| 2026 | 3 | 171 | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K193081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193081: Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193081
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026