De Novo · Granted
GrantedInfluenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centers for Disease Control and Prevention · NXD Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna
Granted on Feb 3, 2006 as a new device type through De Novo after a 7-day review. 64 later devices descend from it.
- Decided
- Feb 3, 2006
- Review
- 7 days
- Class
- Class II
- Product code
- NXD
- Recalls
- None
64 later devices descend from it, 2 citing it directly.
- This deviceDEN060008 Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and…Centers for Disease Control and Prevention · 2006
- Descendant · cites it directly · 59 of its ownK080570 CDC Human Influenza Virus Real-Time RT- PCR Detection and…Centers for Disease Control and Prevention · 2008
- Descendant · 2 generations on · 34 of its ownK100148 Simplexa Influenza a H1N1 (2009) Model MOL2500Focus Diagnostics, Inc. · 2010
- Descendant · 3 generations on · 27 of its ownK103766 Xpert Flu, Genexpert DX Systems, Genexpert Infinity System…Cepheid · 2011 · Recalled
- Descendant · 2 generations on · 19 of its ownK101564 CDC Influenza 2009 a (H1N1)PDM Real-Time RT-PCR PanelCenters for Disease Control and Prevention · 2010
- Descendant · 4 generations on · 18 of its ownK111387 Liat (TM) Influenza a / B Assay, Liat (TM) AnalyzerIquum, Inc. · 2011 · Recalled
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 64 · See all- K080570CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization PanelCenters for Disease Control and Prevention · 2008 · cites it directly59descendants
- K100148Simplexa Influenza a H1N1 (2009) Model MOL2500Focus Diagnostics, Inc. · 2010 · 2 generations on34descendants
- K103766Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System Software…Cepheid · 2011 · 3 generations on27descendants
- K101564CDC Influenza 2009 a (H1N1)PDM Real-Time RT-PCR PanelCenters for Disease Control and Prevention · 2010 · 2 generations on19descendants
- K111387Liat (TM) Influenza a / B Assay, Liat (TM) AnalyzerIquum, Inc. · 2011 · 4 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN060008 | Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set | Centers for Disease Control and Prevention | 2006 | — |
| +1 | K080570 | CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel | Centers for Disease Control and Prevention | 2008 | — |
| +2 | K100148 | Simplexa Influenza a H1N1 (2009) Model MOL2500 | Focus Diagnostics, Inc. | 2010 | — |
| +3 | K103766 | Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System… | Cepheid | 2011 | 1 |
| +2 | K101564 | CDC Influenza 2009 a (H1N1)PDM Real-Time RT-PCR Panel | Centers for Disease Control and Prevention | 2010 | — |
| +4 | K111387 | Liat (TM) Influenza a / B Assay, Liat (TM) Analyzer | Iquum, Inc. | 2011 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 0 |
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NXD? 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (64)
See all 642 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?
- Of its descendants, K080570 (Centers for Disease Control and Prevention, 2008) has gone furthest, with 59 descendants of its own.
How does its category compare?
All NXD devicesNXD Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NXD
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · NXD
Too few NXD 510(k)s in any year since 2007 to give a median.
Recalls per year · NXD
No recall names NXD since 2007.
Adverse event reports per year · NXD
No MAUDE report names NXD since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 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 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN060008 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN060008: Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN060008
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026