510(k) · Cleared
ClearedCDC Influenza 2009 a (H1N1)PDM Real-Time RT-PCR Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centers for Disease Control and Prevention · OQW 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Cleared on Jun 22, 2010 as substantially equivalent to K080570 (Centers for Disease Control and Prevention, 2008) after an 18-day review. Its family tree reaches back 2 generations to 2006. 19 later devices descend from it.
- Decided
- Jun 22, 2010
- Review
- 18 days
- Class
- Class II
- Product code
- OQW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to DEN060008 (2006). 3 ancestors in all. 19 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN060008 Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and…Centers for Disease Control and Prevention · 2006
- 1 generation backK080570 CDC Human Influenza Virus Real-Time RT- PCR Detection and…Centers for Disease Control and Prevention · 2008
- This deviceK101564 CDC Influenza 2009 a (H1N1)PDM Real-Time RT-PCR PanelCenters for Disease Control and Prevention · 2010
- Descendant · cites it directly · 17 of its ownK111507 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention · 2011
- Descendant · 2 generations on · 15 of its ownK130551 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention · 2013
- Descendant · 3 generations on · 14 of its ownK132508 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention · 2013
- Descendant · 4 generations on · 9 of its ownK141859 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel…Centers for Disease Control and Prevention · 2014
- Descendant · 4 generations on · 9 of its ownK140851 Influenza a Subtyping Kit, CDC Human Influenza Virus Real-Time…Centers for Disease Control and Prevention · 2014
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K111507CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention · 2011 · cites it directly17descendants
- K130551CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention · 2013 · 2 generations on15descendants
- K132508CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention · 2013 · 3 generations on14descendants
- K141859CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza a/H5 SubtypingCenters for Disease Control and Prevention · 2014 · 4 generations on9descendants
- K140851Influenza a Subtyping Kit, CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention · 2014 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K101564 | CDC Influenza 2009 a (H1N1)PDM Real-Time RT-PCR Panel | Centers for Disease Control and Prevention | 2010 | — |
| +1 | K111507 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel | Centers for Disease Control and Prevention | 2011 | — |
| +2 | K130551 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel | Centers for Disease Control and Prevention | 2013 | — |
| +3 | K132508 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel | Centers for Disease Control and Prevention | 2013 | — |
| +4 | K141859 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza a/H5… | Centers for Disease Control and Prevention | 2014 | — |
| +4 | K140851 | Influenza a Subtyping Kit, CDC Human Influenza Virus Real-Time RT-PCR… | Centers for Disease Control and Prevention | 2014 | — |
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 |
|---|---|---|
| 2011 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 OQW? 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K0100148 | Focus Simplexa™ Influenza A H1N1 (2009) assay Number could not be read Summary page 5…s): Focus Simplexa Tm Influenza A H1iNi (2009) assay and CDC Human Influenza Virus Real-Time RT- POR Detection and Characterization Panel 2. Predicate 510(k) number(s):_ K01 00148 and K080570 respectively 3. Comparison with predicate: Similarities… | |
| * | K080570 | CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization PanelSummary page 3…nd are noninfectious. The COG rRT-PCR 2009 A(H1 Nl)pdm Flu Panel components used for testing are similar to the components provided in the CDC rRT-PCR Flu Panel ([IVO] [K080570]), following the same instructions for use on the ABI 7500 Fast Dx Real- Time POR system. Intended use The COG Influenza 2009 A(… | 2008 |
What descends from it? (19)
See all 192 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 4 years and passes through 1 company; a new generation was cleared every 2.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K111507 (Centers for Disease Control and Prevention, 2011) has gone furthest, with 17 descendants of its own.
- 7 other devices also cite its predicate K080570.
How does its category compare?
All OQW devicesOQW 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OQW
3in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · OQW
39in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OQW
No recall names OQW since 2007.
Adverse event reports per year · OQW
1in 2011
MAUDE reports naming product code OQW, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 22 | 0 | 0 |
| 2011 | 3 | 83 | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 3 | 39 | 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 CDC Influenza 2009 A(H1N1)pdm Real-Time RT-PCR Panel (CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel) is intended for use in real-time RT-PCR assays on an Applied Biosystems (ABI) 7500 Fa 't Dx Real-Time PCR Instrument in conjunction with clinical and epidemiological information; * For the qualitative detection of influenza virus type A viral RNA from nasopharyngeal swabs (NPS), nasal swabs (NS), nasal aspirates (NA), nasal washes (NW), dual nasopharyngeal /…
Read the full statement (377 words)
The CDC Influenza 2009 A(H1N1)pdm Real-Time RT-PCR Panel (CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel) is intended for use in real-time RT-PCR assays on an Applied Biosystems (ABI) 7500 Fa 't Dx Real-Time PCR Instrument in conjunction with clinical and epidemiological information;
* For the qualitative detection of influenza virus type A viral RNA from nasopharyngeal swabs (NPS), nasal swabs (NS), nasal aspirates (NA), nasal washes (NW), dual nasopharyngeal / throat swabs (NPS/TS), broncheoalveolar lavage (BAL), tracheal aspirate (TA), and bronchial wash (BW), collected from the respiratory tract of human patients with signs and symptoms of respiratory infection and/or from virai culture.
* For differentiation of 2009 H1iN1 influenza virus RNA from nasopharyngeal swabs (NPS), nasal swabs (NS), nasal aspirates (NA), nasal washes (NW) dcual nasopharyngeal / throat swabs (NPS/TS), broncheoalveolar lavage (BAL), tracheal aspirate (TA), and bronchial wash (B3W) collected from the respiratory tract of human patients with signs and symptoms of respiratory infection and/or from viral culture.
* To provide epidemiologic information for surveillance of the 2009 HiNi influenza virus.
Performance characteristics for influenza A were established during the 2009-2010 influenza season when 2009 H1iN1 influenza virus was the predominant influenza A virus in circulation. Performance characteristics may vary against other emerging influenza A viruses.
A negative test result for the broncheoalveolar lavage (BAL), tracheal aspirate (TA), and bronchial wash (B3W) is presumptive and it is recommended these results be confirmed by viral culture.
Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.
If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
All users, analysts, and any person reporting results from use of this device should be trained to perform and interpret the results from this procedure by a competent instructor prior to use. CDC Influenza Division will limit the distribution of this device to only those users who have successfully completed
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101564 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101564: CDC Influenza 2009 a (H1N1)PDM Real-Time RT-PCR Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101564
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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