510(k) · Cleared
ClearedAdenovirus R-Gene US
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Argene SA · OCC Respiratory Virus Panel Nucleic Acid Assay System
Cleared on Feb 8, 2013 as substantially equivalent to K102952 (Gen-Probe Prodesse, Inc., 2010) after a 221-day review. Its family tree reaches back 4 generations to 2008. 1 later device descends from it.
- Decided
- Feb 8, 2013
- Review
- 221 days
- Class
- Class II
- Product code
- OCC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN070013 (2008). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 3 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 2 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- 1 generation backK102952 Prodesse ProadenoGen-Probe Prodesse, Inc. · 2010
- This deviceK121942 Adenovirus R-Gene USArgene SA · 2013
- Descendant · cites it directly · 0 of its ownK141931 Lyra Adenovirus AssayQuidel Corporation · 2014
Most influential descendants
Showing 1 of 1 · See all- K141931Lyra Adenovirus AssayQuidel Corporation · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −3 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −2 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| −1 | K102952 | Prodesse Proadeno | Gen-Probe Prodesse, Inc. | 2010 | — |
| 0 (this device) | K121942 | Adenovirus R-Gene US | Argene SA | 2013 | — |
| +1 | K141931 | Lyra Adenovirus Assay | Quidel Corporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 OCC? 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 OCC device
- #1 K262747 ID NOW Influenza A & B 2; ID NOW RSV; ID NOW…score 15.2 · 12 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 |
|---|---|---|---|
| * | K102952 | Prodesse ProadenoSummary page 3…ect of this submission is claimed equivalent to the Gen-Probe Prodesse Incorporated test, which received 510(k) clearance from FDA as the Prodesse® ProAdlenom+ Assay, #K102952, cleared on 03-Decenmber-201 0. Device to which comparison is claimed The comparison is performed against culture on shell via… | 2010 |
| † | K061101 | D3 Ultra Dfa Respiratory Virus Screening & ID Kit | 2006 |
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 |
|---|---|---|---|
| K141931 | Lyra Adenovirus Assay | 2014 | 0 |
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 5 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K141931 (Quidel Corporation, 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K102952.
How does its category compare?
All OCC devicesOCC Respiratory Virus Panel Nucleic Acid Assay System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OCC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OCC
31in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCC
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCC
2in 2025
MAUDE reports naming product code OCC, 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 | 4 | 28 | 0 | 0 |
| 2009 | 6 | 24 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 9 | 82 | 0 | 2 |
| 2012 | 6 | 125 | 0 | 1 |
| 2013 | 6 | 79 | 0 | 0 |
| 2014 | 4 | 94 | 1 | 52 |
| 2015 | 8 | 85 | 0 | 1 |
| 2016 | 7 | 92 | 0 | 36 |
| 2017 | 10 | 136 | 0 | 1 |
| 2018 | 4 | 134 | 1 | 1 |
| 2019 | 5 | 31 | 1 | 2 |
| 2020 | 2 | — | 0 | 17 |
| 2021 | 1 | — | 0 | 686 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 1 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 3 | 130 | 0 | — |
What is it indicated for?
Adenovirus R-gene® US Assay is a Real Time PCR in vitro diagnostic test for the rapid and qualitative detection of Adenovirus viral DNA isolated and purified from nasopharyngeal swab or nasopharyngeal wash/aspirate specimens obtained from individuals exhibiting signs and symptoms of acute respiratory infection. The intended use for this test is to aid in the diagnosis of respiratory Adenovirus infection in humans in conjunction with other clinical and…
Read the full statement (110 words)
Adenovirus R-gene® US Assay is a Real Time PCR in vitro diagnostic test for the rapid and qualitative detection of Adenovirus viral DNA isolated and purified from nasopharyngeal swab or nasopharyngeal wash/aspirate specimens obtained from individuals exhibiting signs and symptoms of acute respiratory infection. The intended use for this test is to aid in the diagnosis of respiratory Adenovirus infection in humans in conjunction with other clinical and laboratory findings. The test detects, but does not differentiate, Adenovirus species (A, B, C, D, E, F and G). Negative results do not preclude Adenovirus infection and should not be used as the sole basis for treatment or other patient management decisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121942: Adenovirus R-Gene US.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121942
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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