# K080570: CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel

- Pathway: 510(k) (Traditional)
- Applicant: Centers for Disease Control and Prevention
- Decided: Sep 30, 2008 after 214 days
- Product code: NXD (Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna)
- 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: 1 generation back to DEN060008 (2006). 2 ancestors in all.
59 later devices descend from it; 8 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN060008: Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set, Centers for Disease Control and Prevention (2006). 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.
- K073029: Proflu+ Assay, Prodesse, Inc. (2008) Summary page 3.

## Most influential descendants
- K100148: Simplexa Influenza a H1N1 (2009) Model MOL2500 (2010), 34 descendants of its own
- K103766: Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System Software Verisions 2.1 and 4.0 (2011), 27 descendants of its own
- K101564: CDC Influenza 2009 a (H1N1)PDM Real-Time RT-PCR Panel (2010), 19 descendants of its own
- K111387: Liat (TM) Influenza a / B Assay, Liat (TM) Analyzer (2011), 18 descendants of its own
- K111507: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (2011), 17 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K080570
Methodology: https://510kreport.com/methodology