# K101564: CDC Influenza 2009 a (H1N1)PDM Real-Time RT-PCR Panel

- Pathway: 510(k) (Traditional)
- Applicant: Centers for Disease Control and Prevention
- Decided: Jun 22, 2010 after 18 days
- Product code: OQW (2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification)
- Device class: 2
- Regulation: 21 CFR 866.3332
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN060008 (2006). 3 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080570: CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel, Centers for Disease Control and Prevention (2008) Summary page 3.

## Cited in the summary but kept off the family tree
- K0100148: Focus Simplexa™ Influenza A H1N1 (2009) assay. Number could not be read Summary page 5.

## Most influential descendants
- K111507: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (2011), 17 descendants of its own
- K130551: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (2013), 15 descendants of its own
- K132508: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (2013), 14 descendants of its own
- K141859: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza a/H5 Subtyping (2014), 9 descendants of its own
- K140851: Influenza a Subtyping Kit, CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (2014), 9 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K101564
Methodology: https://510kreport.com/methodology