510(k) · Cleared
ClearedLyra Adenovirus Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corporation · OCC Respiratory Virus Panel Nucleic Acid Assay System
Cleared on Oct 9, 2014 as substantially equivalent to K121942 (Argene SA, 2013) after an 85-day review. Its family tree reaches back 5 generations to 2008.
- Decided
- Oct 9, 2014
- Review
- 85 days
- Class
- Class II
- Product code
- OCC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN070013 (2008). No later device cites it as a predicate yet.
- Root · 5 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 4 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 3 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- 2 generations backK102952 Prodesse ProadenoGen-Probe Prodesse, Inc. · 2010
- 1 generation backK121942 Adenovirus R-Gene USArgene SA · 2013
- This deviceK141931 Lyra Adenovirus AssayQuidel Corporation · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −4 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −3 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| −2 | K102952 | Prodesse Proadeno | Gen-Probe Prodesse, Inc. | 2010 | — |
| −1 | K121942 | Adenovirus R-Gene US | Argene SA | 2013 | — |
| 0 (this device) | K141931 | Lyra Adenovirus Assay | Quidel Corporation | 2014 | — |
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 |
|---|---|---|---|
| * | K121942 | Adenovirus R-Gene USSummary page 5…of 14 Section 05, 510(k) Summary Item Subject Device Predicate Device Lyra™ Adenovirus (K121942) Assay Adenovirus R-gene… | 2013 |
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 6 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 5 ancestors have a recall of any class.
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. 2014, 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?
The Lyra™ Adenovirus Assay is a real‐time polymerase chain reaction (PCR) in vitro diagnostic test for the qualitative detection of human adenovirus (HAdV) viral DNA isolated from nasal and nasopharyngeal swab specimens obtained from individuals exhibiting signs and symptoms of acute respiratory infections. The intended use of this test is to aid in the diagnosis of HAdV in conjunction with other clinical and laboratory findings.
The test detects, but does not differentiate, HAdV species (A, B, C, D, E, and F) or serotypes (HAdV 1-52).
Negative results do not preclude HAdV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141931: Lyra Adenovirus Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141931
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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