510(k) · Cleared
ClearedNxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Luminex Molecular Diagnostics, Inc. · QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Cleared on Mar 11, 2024 as substantially equivalent to DEN200031 (Biofire Diagnostics, LLC, 2021) after a 269-day review. Its family tree reaches back 1 generation to 2021.
- Decided
- Mar 11, 2024
- Review
- 269 days
- Class
- Class II
- Product code
- QOF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200031 (2021). No later device cites it as a predicate yet.
- Root · 1 generation backDEN200031 BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC · 2021
- This deviceK231758 NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)Luminex Molecular Diagnostics, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN200031 | BioFire Respiratory Panel 2.1 (RP2.1) | Biofire Diagnostics, LLC | 2021 | — |
| 0 (this device) | K231758 | NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) | Luminex Molecular Diagnostics, Inc. | 2024 | — |
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 |
|---|---|---|---|
| * | DEN200031 | BioFire Respiratory Panel 2.1 (RP2.1)Summary page 9…. Substantial Equivalence Information: 1. Predicate device name(s): BioFire Respiratory Panel 2.1 (RP2.1) 2. Predicate 510(k) number(s): DEN200031 3. Comparison with predicate: Device & Predicate Device(s): K231758 DEN200031 D… | 2021 |
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?
- Its one ancestor has no recall.
- 12 other devices also cite its predicate DEN200031.
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. 2024, 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 NxTAG® Respiratory Pathogen Panel v2 (NxTAG® RPP v2) is a multiplexed polymerase chain reaction (PCR) test intended for the simultaneous, qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swab specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19. The following organism types and subtypes are identified and differentiated using…
Read the full statement (312 words)
The NxTAG® Respiratory Pathogen Panel v2 (NxTAG® RPP v2) is a multiplexed polymerase chain reaction (PCR) test
intended for the simultaneous, qualitative detection and identification of multiple respiratory viral and bacterial nucleic
acids in nasopharyngeal swab specimens obtained from individuals with signs and symptoms of respiratory tract infection,
including COVID-19.
The following organism types and subtypes are identified and differentiated using the NxTAG RPPv2:
Viral Targets: Influenza A, Influenza A H1, Influenza A H1pdm09, Influenza A H3, Influenza B, Respiratory Syncytial
Virus A, Respiratory Syncytial Virus B, SARS-CoV-2, Coronavirus 229E, Coronavirus OC43, Coronavirus NL63,
Coronavirus HKU1, Human Metapneumovirus, Rhinovirus/Enterovirus, Adenovirus, Parainfluenza 1, Parainfluenza 2,
Parainfluenza 3, Parainfluenza 4
Bacterial Targets: Chlamydia pneumoniae, Mycoplasma pneumoniae
Nucleic acids from the viral and bacterial organisms identified by this test are generally detectable in nasopharyngeal
specimens during the acute phase of infection. The detection and identification of specific viral and bacterial nucleic acids
from individuals exhibiting signs and/or symptoms of respiratory infection are indicative of the presence of the identified
microorganism and aids in diagnosis if used in conjunction with other clinical and epidemiological information, 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 setting of a respiratory illness may be due to infection with pathogens that are not detected by this
test, or lower respiratory tract infection that may not be detected by a nasopharyngeal swab specimen. Positive results do
not rule out coinfection with other organisms. The agent(s) detected by the NxTAG RPP v2 may not be the definite cause
of disease.
Additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary
when evaluating a patient with possible respiratory tract infection.
The NxTAG® Respiratory Pathogen Panel v2 is indicated for use with the Luminex® MAGPIX® Instrument and
xPONENT® and SYNCT™ software.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231758 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231758: NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231758
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026