De Novo · Granted
GrantedBioFire Respiratory Panel 2.1 (RP2.1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofire Diagnostics, LLC · QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Granted on Mar 17, 2021 as a new device type through De Novo after a 302-day review. 46 later devices descend from it.
- Decided
- Mar 17, 2021
- Review
- 302 days
- Class
- Class II
- Product code
- QOF
- Recalls
- None
46 later devices descend from it, 13 citing it directly.
- This deviceDEN200031 BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC · 2021
- Descendant · cites it directly · 11 of its ownK211079 BioFire COVID-19 Test 2Biofire Defense, LLC · 2021
- Descendant · cites it directly · 6 of its ownK222736 Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc. · 2023 · Recalled
- Descendant · cites it directly · 6 of its ownK213954 BIOFIRE SPOTFIRE Respiratory (R) PanelBiofire Diagnostics · 2023
- Descendant · 2 generations on · 4 of its ownK241240 Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc. · 2024
- Descendant · cites it directly · 4 of its ownK231481 Xpert Xpress CoV-2/Flu/RSV plusCepheid® · 2023
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K211079BioFire COVID-19 Test 2Biofire Defense, LLC · 2021 · cites it directly11descendants
- K222736Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc. · 2023 · cites it directly6descendants
- K213954BIOFIRE SPOTFIRE Respiratory (R) PanelBiofire Diagnostics · 2023 · cites it directly6descendants
- K241240Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc. · 2024 · 2 generations on4descendants
- K231481Xpert Xpress CoV-2/Flu/RSV plusCepheid® · 2023 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN200031 | BioFire Respiratory Panel 2.1 (RP2.1) | Biofire Diagnostics, LLC | 2021 | — |
| +1 | K211079 | BioFire COVID-19 Test 2 | Biofire Defense, LLC | 2021 | — |
| +1 | K222736 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Hologic, Inc. | 2023 | 1 |
| +1 | K213954 | BIOFIRE SPOTFIRE Respiratory (R) Panel | Biofire Diagnostics | 2023 | — |
| +2 | K241240 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Hologic, Inc. | 2024 | — |
| +1 | K231481 | Xpert Xpress CoV-2/Flu/RSV plus | Cepheid® | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 9 | 0 |
| 2024 | 11 | 0 |
| 2025 | 16 | 0 |
| 2026 | 6 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (46)
See all 4613 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211079 | BioFire COVID-19 Test 2 | 2021 | 11 |
| K222736 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | 2023 | 6 |
| K213954 | BIOFIRE SPOTFIRE Respiratory (R) Panel | 2023 | 6 |
| K231481 | Xpert Xpress CoV-2/Flu/RSV plus | 2023 | 4 |
| K233100 | QIAstat-Dx® Respiratory Panel Plus | 2024 | 3 |
| K220963 | Simplexa COVID-19 & Flu A/B Direct | 2023 | 3 |
| K223591 | cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System | 2023 | 1 |
| K263054 | BIOFIRE Respiratory Panel 2.1 (RP2.1) | 2026 | 0 |
| K243455 | cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems | 2025 | 0 |
| K241806 | Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel | 2025 | 0 |
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?
- Of its descendants, K211079 (Biofire Defense, LLC, 2021) has gone furthest, with 11 descendants of its own.
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. 2021, 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 BioFire Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BioFire FilmArray 2.0 or BioFire FilmArray Torch systems for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections, including COVID-19. The following organism types and subtypes are…
Read the full statement (300 words)
The BioFire Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BioFire FilmArray 2.0 or BioFire FilmArray Torch systems for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections, including COVID-19.
The following organism types and subtypes are identified using the BioFire RP2.1:
Adenovirus,
Coronavirus 229E,
Coronavirus HKU1,
Coronavirus NL63,
Coronavirus OC43,
Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2),
Human Metapneumovirus,
Human Rhinovirus/Enterovirus,
Influenza A, including subtypes H1, H1-2009, and H3,
Influenza B,
Parainfluenza Virus 1,
Parainfluenza Virus 2,
Parainfluenza Virus 3,
Parainfluenza Virus 4,
Respiratory Syncytial Virus,
Bordetella parapertussis (IS1001),
Bordetella pertussis (ptxP),
Chlamydia pneumoniae, and
Mycoplasma pneumoniae
Nucleic acids from the respiratory viral and bacterial organisms identified by this test are generally detectable in NPS 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 is indicative of the presence of the identified microorganism and aids in the diagnosis of respiratory infection if used in conjunction with other clinical and epidemiological information. 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 an NPS specimen. Positive results do not rule out coinfection with other organisms. The agent(s) detected by the BioFire RP2.1 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.
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/DEN200031 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN200031: BioFire Respiratory Panel 2.1 (RP2.1).” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN200031
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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