510(k) · Cleared
ClearedProdesse Proadeno
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gen-Probe Prodesse, Inc. · OCC Respiratory Virus Panel Nucleic Acid Assay System
Cleared on Dec 3, 2010 as substantially equivalent to DEN070013 (Luminex Molecular Diagnostics, Inc., 2008) and 2 other predicates after a 59-day review. Its family tree reaches back 3 generations to 2008. 3 later devices descend from it.
- Decided
- Dec 3, 2010
- Review
- 59 days
- Class
- Class II
- Product code
- OCC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to DEN070013 (2008). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 2 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 1 generation backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- This deviceK102952 Prodesse ProadenoGen-Probe Prodesse, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK121942 Adenovirus R-Gene USArgene SA · 2013
- Descendant · 2 generations on · 0 of its ownK141931 Lyra Adenovirus AssayQuidel Corporation · 2014
- Descendant · cites it directly · 0 of its ownK132159 Proadeno+ AssayGen-Probe Prodesse, Inc. · 2013
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −2 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −1 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| 0 (this device) | K102952 | Prodesse Proadeno | Gen-Probe Prodesse, Inc. | 2010 | — |
| +1 | K121942 | Adenovirus R-Gene US | Argene SA | 2013 | — |
| +2 | K141931 | Lyra Adenovirus Assay | Quidel Corporation | 2014 | — |
| +1 | K132159 | Proadeno+ Assay | Gen-Probe Prodesse, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | DEN070013 | ID-Tag Respiratory Viral Panel Our reading of the summary gave K063765, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN070013, ID-Tag Respiratory Viral Panel (Luminex Molecular Diagnostics, Inc.), granted Jan 3, 2008; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2008 |
| * | K081483 | Xtag Respiratory Viral PanelSummary page 1…Tm+ Assay Regulation Number: 21 CFR 866.3980 Classification Name: Respiratory viral panel multiplex nucleic acid assay PREDICATE DEVICE K063765, K081483, K091667 - ID Tag Respiratory Virus Panel, Luminex Molecular Diagnostics INTENDED USE The ProAdenoTv+ Assay is a multiplex… | 2008 |
| * | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112, I019E0113, S019-0116Summary page 1…Regulation Number: 21 CFR 866.3980 Classification Name: Respiratory viral panel multiplex nucleic acid assay PREDICATE DEVICE K063765, K081483, K091667 - ID Tag Respiratory Virus Panel, Luminex Molecular Diagnostics INTENDED USE The ProAdenoTv+ Assay is a multiplex Real Tim… | 2009 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 2 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K121942 (Argene SA, 2013) has gone furthest, with 1 descendant of its own.
- 11 other devices also cite its predicate DEN070013.
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. 2010, 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 ProAdeno+ Assay is a multiplex Real Time PCR in vitro diagnostic test for the qualitative detection of human Adenovirus (HAdV) DNA isolated and purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of acute respiratory infection. This test is intended for use to aid in the diagnosis of HAdV infections in humans in conjunction with other clinical and laboratory findings. The test detects, but does not differentiate, serotypes 1-51.
Negative results do not preclude HAdV 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/K102952 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102952: Prodesse Proadeno.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102952
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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