# K180218: Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV

- Pathway: 510(k) (Dual Track)
- Applicant: Cepheid
- Decided: Jul 24, 2018 after 180 days
- Product code: OCC (Respiratory Virus Panel Nucleic Acid Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to DEN070013 (2008). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151226: Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I), Cepheid (2015) Summary page 5.
- K171552: Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV, Cepheid (2017) Summary page 5.

## Indications for use
The Cepheid Xpert® Xpress Flu/RSV Assay, performed on the GeneXpert® Xpress System, is an automated, multiplex real-time, reverse transcriptase polymerase chain reaction (RT-PCR) assay intended for the in vitro qualitative detection and differentiation of influenza A, influenza B, and respiratory syncytial virus (RSV) viral RNA. The Xpert Xpress Flu/RSV Assay uses nasopharyngeal (NP) swab and nasal swab (NS) specimens collected from patients with signs and symptoms of respiratory infection. The Xpert Xpress Flu/RSV Assay is intended as an aid in the diagnosis of influenza and respiratory syncytial virus infections in conjunction with clinical and epidemiological risk factors. Negative results do not preclude influenza virus 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 2016-2017 influenza season when influenza A/H3N2 and A/HINI pandemic were the predominant influenza A viruses in circulation. When other novel 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 departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. The Xpert® Nasopharyngeal Sample Collection Kit is designed to collect, preserve, and transport nasopharyngeal swab specimens and to preserve and transport nasal aspirate/wash specimens containing viruses from patients with signs and symptoms of respiratory infection prior to analysis with the Xpert Flu Assay or the Xpert Flu/RSV XC Assay. The Xpert® Nasopharyngeal Sample Collection Kit is designed to collect, preserve, and transport nasopharyngeal swab specimens containing viruses from patients with signs and symptoms of respiratory infection prior to analysis with the Xpert Flu+RSV Xpress Assay, Xpert Xpress Flu/RSV Assay or the Xpert Xpress Flu Assay. The Xpert® Nasal Sample Collection Kit is designed to collect, preserve, and transport nasal swab specimens containing viruses from patients with signs and symptoms of respiratory infection prior to analysis with the Xpert Xpress Flu/RSV Assay and the Xpert Xpress Flu Assay.

Source page: https://510kreport.com/device/K180218
Methodology: https://510kreport.com/methodology