# K103766: Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System Software Verisions 2.1 and 4.0

- Pathway: 510(k) (Traditional)
- Applicant: Cepheid
- Decided: Apr 21, 2011 after 119 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN070013 (2008). 7 ancestors in all.
27 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073029: Proflu+ Assay, Prodesse, Inc. (2008) Summary page 1.
- K100148: Simplexa Influenza a H1N1 (2009) Model MOL2500, Focus Diagnostics, Inc. (2010) Summary page 1.

## Most influential descendants
- K111387: Liat (TM) Influenza a / B Assay, Liat (TM) Analyzer (2011), 18 descendants of its own
- K141520: Alere I Influenza a & B (2014), 11 descendants of its own
- K151464: Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit (2015), 8 descendants of its own
- K163266: Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument (2016), 7 descendants of its own
- K120911: Xpert Flu  Genexpert DX Systems (GX-I, GX-IV) (2012), 7 descendants of its own

## Recalls of this device
- Apr 1, 2011 · Not classified · Z-2401-2011: A mismatch of Patient ID or Sample ID and the Host Order from the hosted LIS and its requested test results could occur when running in batch mode and cartridges are introduced in rapid succession.

## Indications for use
The Cepheid@ Xpert Flu Assay is an automated, multiplex real-time RT-PCR assay intended for the in vitro qualitative detection and differentiation of influenza A, influenza B and 2009 H IN I influenza viral RNA. The Xpert Flu Assay uses nasal aspirates/washes and nasopharyngeal swab specimens collected from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. The Xpert Flu Assay is intended as an aid in the diagnosis of influenza. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2009-2010 influenza season when 2009 HIMi influenza was the predominant influenza A virus in circulation. When other influenza A viruses are emerging, performance characteristics may vary. 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.

Source page: https://510kreport.com/device/K103766
Methodology: https://510kreport.com/methodology