# K261336: Xpert Respiratory Panel

- Pathway: 510(k) (Traditional)
- Applicant: Cepheid
- Decided: Sep 25, 2026 after 155 days
- Product code: QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents)
- Device class: 2
- Regulation: 21 CFR 866.3981
- 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 DEN200031 (2021). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233100: QIAstat-Dx® Respiratory Panel Plus, QIAGEN GmbH (2024) Summary page 8.

## Indications for use
The Xpert Respiratory Panel test, performed on the GeneXpert Instrument Systems, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of DNA and RNA from multiple bacteria and/or viruses in nasopharyngeal swab (NPS) specimens obtained from individuals with clinical signs and symptoms of respiratory tract infection. The following organism types and subtypes are identified using the Xpert Respiratory Panel test: • Adenovirus (A-E) • Coronavirus (HKU1, NL63, 229E, OC43) • SARS-CoV-2 • Human Metapneumovirus • Rhinovirus/Enterovirus • Parainfluenza (1-4) • Influenza A • Influenza B • Respiratory Syncytial Virus (A and B) • Bordetella pertussis • Bordetella parapertussis • Mycoplasma pneumoniae • Chlamydia pneumoniae Nucleic acids from viral and bacterial organisms identified by this test are generally detectable in NPS specimens during the acute phase of infection. Detecting and identifying specific viral and bacterial nucleic acids from individuals presenting with signs and symptoms of a respiratory infection aids in the diagnosis of respiratory infection, if used in conjunction with other clinical, epidemiological and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Negative results in the presence of a respiratory illness may be due to infection with pathogens that are not detected by the test, or due to lower respiratory tract infection that is not detected by a NPS specimen. Conversely, positive results are indicative of the presence of the identified microorganism, but do not rule out co-infection with other pathogens not detected by the Xpert Respiratory Panel. The agent(s) detected by the Xpert Respiratory Panel may not be the definite cause of disease. The use of additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection.

Source page: https://510kreport.com/device/K261336
Methodology: https://510kreport.com/methodology