510(k) · Cleared
Clearedartus HSV-1/2 QS-RGQ MDx Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qiagen · OQO Herpes Simplex Virus Nucleic Acid Amplification Assay
Cleared on Dec 19, 2014 as substantially equivalent to K100336 (Eragen Biosciences, 2010) after an 87-day review. Its family tree reaches back 2 generations to 1997. 1 of the 4 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Dec 19, 2014
- Review
- 87 days
- Class
- Class II
- Product code
- OQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K971662 (1997). 1 later device descends from it, 1 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK971662 Elvis HSV ID/Typing Test SystemDiagnostic Hybrids, Inc. · 1997
- 1 generation backK100336 Multicode - RTX Herpes Simplex Virus 1 and 2 Kit, Model 3711Eragen Biosciences · 2010
- This deviceK142738 artus HSV-1/2 QS-RGQ MDx KitQiagen · 2014
- Descendant · cites it directly · 0 of its ownK150962 Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackFocus Diagnostics · 2015 · Recalled (Class I)
Class I recalls in this family
- K150962 Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2…cites it directly · 2015
Most influential descendants
Showing 1 of 1 · See all- K150962Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackFocus Diagnostics · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971662 | Elvis HSV ID/Typing Test System | Diagnostic Hybrids, Inc. | 1997 | — |
| −1 | K100336 | Multicode - RTX Herpes Simplex Virus 1 and 2 Kit, Model 3711 | Eragen Biosciences | 2010 | — |
| 0 (this device) | K142738 | artus HSV-1/2 QS-RGQ MDx Kit | Qiagen | 2014 | — |
| +1 | K150962 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack | Focus Diagnostics | 2015 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 1 |
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.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K100336 | Multicode - RTX Herpes Simplex Virus 1 and 2 Kit, Model 3711Summary page 4…cate Device Manufacturer Product Name 510(k) No. Eragen Biosciences MultiCode®-RTx Herpes Simplex Virus 1 K100336 & 2 Kit Device Description The artus HSV-1/2 QS-RGQ MDx Kit is an in vitro PCR assay for the qualitativ… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150962 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack Class I | 2015 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K150962Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackFocus Diagnostics · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 12.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K150962 (Focus Diagnostics, 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K100336.
How does its category compare?
All OQO devicesOQO Herpes Simplex Virus Nucleic Acid Amplification Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OQO
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · OQO
140in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OQO
No recall names OQO since 2007.
Adverse event reports per year · OQO
1in 2025
MAUDE reports naming product code OQO, 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 | 1 | — | 0 | 0 |
| 2011 | 3 | 81 | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 3 | 87 | 0 | 0 |
| 2015 | 3 | 140 | 0 | 0 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The artus HSV-1/2 QS-RGQ MDx Kit is an in vitro real-time PCR DNA amplification assay performed on the QIAsymphony RGQ MDx system for the direct qualitative detection and differentiation of herpes simplex virus (HSV-1 and HSV-2) DNA in genital or oral vesicular lesions from male and female patients suspected of HSV infection.
The assay is intended for use as an aid in diagnosis of HSV infection in symptomatic patients.
Warning: The artus HSV-1/2 QS-RGQ MDx Kit is not FDA-cleared for use with cerebrospinal fluid (CSF) or for prenatal screening.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142738 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142738: artus HSV-1/2 QS-RGQ MDx Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142738
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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