510(k) · Cleared
ClearedXpert Respiratory Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cepheid · QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Cleared on Sep 25, 2026 as substantially equivalent to K233100 (QIAGEN GmbH, 2024) after a 155-day review. Its family tree reaches back 2 generations to 2021.
- Decided
- Sep 25, 2026
- Review
- 155 days
- Class
- Class II
- Product code
- QOF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN200031 (2021). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QOF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QOF device
- #1 K241240 Panther Fusion SARS-CoV-2/Flu A/B/RSV Assayscore 17.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K233100 | QIAstat-Dx® Respiratory Panel PlusSummary page 8…lassification Advisory Microbiology (83) Panel Prescription Use Yes Predicate Device Assay QIAstat-Dx® Respiratory Panel Plus (K233100) 510(k) Summary Page 3 of 40 Xpert® Respir… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K233100.
How does its category compare?
All QOF devicesQOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QOF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QOF
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QOF
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QOF
10in 2025
MAUDE reports naming product code QOF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 7 | 238 | 1 | 6 |
| 2024 | 9 | 147 | 1 | 30 |
| 2025 | 13 | 178 | 1 | 10 |
| 2026 | 8 | 128 | 2 | — |
What is it indicated for?
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…
Read the full statement (299 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261336 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261336: Xpert Respiratory Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261336
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026