510(k) · Cleared
ClearedCDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel
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
Cleared on Sep 30, 2008 as substantially equivalent to DEN060008 (Centers for Disease Control and Prevention, 2006) and 1 other predicate after a 214-day review. Its family tree reaches back 1 generation to 2006. 59 later devices descend from it.
- Decided
- Sep 30, 2008
- Review
- 214 days
- Class
- Class II
- Product code
- NXD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to DEN060008 (2006). 2 ancestors in all. 59 later devices descend from it, 8 citing it directly.
- Root · 1 generation backDEN060008 Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and…Centers for Disease Control and Prevention · 2006
- This deviceK080570 CDC Human Influenza Virus Real-Time RT- PCR Detection and…Centers for Disease Control and Prevention · 2008
- Descendant · cites it directly · 34 of its ownK100148 Simplexa Influenza a H1N1 (2009) Model MOL2500Focus Diagnostics, Inc. · 2010
- Descendant · 2 generations on · 27 of its ownK103766 Xpert Flu, Genexpert DX Systems, Genexpert Infinity System…Cepheid · 2011 · Recalled
- Descendant · cites it directly · 19 of its ownK101564 CDC Influenza 2009 a (H1N1)PDM Real-Time RT-PCR PanelCenters for Disease Control and Prevention · 2010
- Descendant · 3 generations on · 18 of its ownK111387 Liat (TM) Influenza a / B Assay, Liat (TM) AnalyzerIquum, Inc. · 2011 · Recalled
- Descendant · cites it directly · 17 of its ownK111507 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention · 2011
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K100148Simplexa Influenza a H1N1 (2009) Model MOL2500Focus Diagnostics, Inc. · 2010 · cites it directly34descendants
- K103766Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System Software…Cepheid · 2011 · 2 generations on27descendants
- K101564CDC Influenza 2009 a (H1N1)PDM Real-Time RT-PCR PanelCenters for Disease Control and Prevention · 2010 · cites it directly19descendants
- K111387Liat (TM) Influenza a / B Assay, Liat (TM) AnalyzerIquum, Inc. · 2011 · 3 generations on18descendants
- K111507CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention · 2011 · cites it directly17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN060008 | Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set | Centers for Disease Control and Prevention | 2006 | — |
| 0 (this device) | K080570 | CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel | Centers for Disease Control and Prevention | 2008 | — |
| +1 | K100148 | Simplexa Influenza a H1N1 (2009) Model MOL2500 | Focus Diagnostics, Inc. | 2010 | — |
| +2 | K103766 | Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System… | Cepheid | 2011 | 1 |
| +1 | K101564 | CDC Influenza 2009 a (H1N1)PDM Real-Time RT-PCR Panel | Centers for Disease Control and Prevention | 2010 | — |
| +3 | K111387 | Liat (TM) Influenza a / B Assay, Liat (TM) Analyzer | Iquum, Inc. | 2011 | 4 |
| +1 | K111507 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel | Centers for Disease Control and Prevention | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 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
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | DEN060008 | Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set Our reading of the summary gave K060159, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN060008, Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR… (Centers for Disease Control and Prevention), granted Feb 3, 2006; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2006 |
| * | K073029 | Proflu+ AssaySummary page 3…lineage) Virus Real-time RT-PCR ProFlu+TM RT-PCR Primers and Assay (K073029) Probe Set (K060159)… | 2008 |
What descends from it? (59)
See all 598 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100148 | Simplexa Influenza a H1N1 (2009) Model MOL2500 | 2010 | 34 |
| K101564 | CDC Influenza 2009 a (H1N1)PDM Real-Time RT-PCR Panel | 2010 | 19 |
| K111507 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel | 2011 | 17 |
| K101855 | Profast+ Assay | 2010 | 5 |
| K111775 | Jbaids Influenza a&B Detection Kit | 2011 | 1 |
| K111778 | Jbaids Influenza a Subtyping Kit | 2011 | 0 |
| K100287 | Jbaids Influenza a/H5 Detection Kit, Model JRPD-Asy-0136 | 2010 | 0 |
| K083278 | Avc a/H5N1 Flu Test | 2009 | 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?
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. 2008, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel) is intended for use in Real-time RT-PCR assays on an ABI 7500 Fast Dx Real-time PCR instrument in conjunction with clinical and epidemiological information: * for qualitative detection of influenza virus type A or B in symptomatic patients from viral RNA in nasopharyngeal and/or nasal swab specimens, * for determination of the subtype of seasonal human…
Read the full statement (324 words)
The Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel) is intended for use in Real-time RT-PCR assays on an ABI 7500 Fast Dx Real-time PCR instrument in conjunction with clinical and epidemiological information:
* for qualitative detection of influenza virus type A or B in symptomatic patients from viral RNA in nasopharyngeal and/or nasal swab specimens,
* for determination of the subtype of seasonal human influenza A virus, as seasonal A/H I or A/H3, if present, from viral RNA in nasopharyngeal and/or nasal swab specimens,
* for presumptive identification of virus in patients who may be infected with influenza A subtype A/H5 (Asian lineage) from viral RNA in human respiratory specimens and viral culture in conjunction with clinical and epidemiological risk factors.
* to provide epidemiologic information for surveillance for influenza viruses.
Performance characteristics for influenza A were established when influenza A/H3 and A/HI were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.
Testing with the influenza H5a and H5b primer and probe sets should not be performed unless the patient meets the most current U.S. Department of Health and Human Services (DHHS) clinical and epidemiologic criteria for testing suspect A/H5 specimens. The definitive identification of influenza A/H5 (Asian lineage) either directly from patient specimens or from virus cultures requires additional laboratory testing, along with clinical and epidemiological assessment in consultation with national influenza surveillance experts.
Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.
All users, analysts, and any person reporting diagnostic results from use of this device should be trained to perform and interpret the results from this procedure by a CDC instructor or designee prior to use. CDC Influenza Division will limit the distribution of this device to only those users who have successfully completed training provided by CDC instructors or designees.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080570 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080570: CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080570
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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