510(k) · Cleared
ClearedBIOFIRE SPOTFIRE Respiratory (R) Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofire Diagnostics · QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Cleared on Feb 3, 2023 as substantially equivalent to DEN200031 (Biofire Diagnostics, LLC, 2021) after a 413-day review. Its family tree reaches back 1 generation to 2021. 6 later devices descend from it.
- Decided
- Feb 3, 2023
- Review
- 413 days
- Class
- Class II
- Product code
- QOF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200031 (2021). 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN200031 BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC · 2021
- This deviceK213954 BIOFIRE SPOTFIRE Respiratory (R) PanelBiofire Diagnostics · 2023
- Descendant · cites it directly · 2 of its ownK232954 BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) PanelBiofire Diagnostics, LLC · 2024 · Recalled
- Descendant · cites it directly · 2 of its ownK230719 BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBiofire Diagnostics, LLC · 2023
- Descendant · 2 generations on · 1 of its ownK241194 BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel MiniBiofire Diagnostics, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK251978 Liaison Nes Flu a/B, RSV & Covid-19Diasorin Molecular, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK243544 BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniBiofire Diagnostics, LLC · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K232954BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) PanelBiofire Diagnostics, LLC · 2024 · cites it directly2descendants
- K230719BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBiofire Diagnostics, LLC · 2023 · cites it directly2descendants
- K241194BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel MiniBiofire Diagnostics, LLC · 2024 · 2 generations on1descendant
- K251978Liaison Nes Flu a/B, RSV & Covid-19Diasorin Molecular, LLC · 2025 · 2 generations on0descendants
- K243544BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniBiofire Diagnostics, LLC · 2025 · 3 generations on0descendants
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) | K213954 | BIOFIRE SPOTFIRE Respiratory (R) Panel | Biofire Diagnostics | 2023 | — |
| +1 | K232954 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel | Biofire Diagnostics, LLC | 2024 | 1 |
| +1 | K230719 | BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini | Biofire Diagnostics, LLC | 2023 | — |
| +2 | K241194 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini | Biofire Diagnostics, LLC | 2024 | — |
| +2 | K251978 | Liaison Nes Flu a/B, RSV & Covid-19 | Diasorin Molecular, LLC | 2025 | — |
| +3 | K243544 | BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini | Biofire Diagnostics, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
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 5…tion Number: 21 CFR 866.3981 Classification Name: Multi-target Respiratory Specimen Nucleic Acid Test Including SARS-CoV-2 and Other Microbial Agents Predicate Device: DEN200031 – BIOFIRE® Respiratory Panel 2.1 (RP2.1) Intended Use: The BIOFIRE® SPOTFIRE® Respiratory (R) Panel (SPOTFIRE R Panel) is a mul… | 2021 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2023, 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® SPOTFIRE® Respiratory (R) Panel (SPOTFIRE R Panel) is a multiplexed polymerase chain reaction (PCR) test intended for use with the BIOFIRE® SPOTFIRE® System for the simultaneous, qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swab (NPS) specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19. The following organism…
Read the full statement (288 words)
The BIOFIRE® SPOTFIRE® Respiratory (R) Panel (SPOTFIRE R Panel) is a multiplexed polymerase chain reaction (PCR) test intended for use with the BIOFIRE® SPOTFIRE® System for the simultaneous, qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swab (NPS) 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 SPOTFIRE R Panel:
Viruses:
Adenovirus
Coronavirus (seasonal)
Coronavirus SARS-CoV-2
Human metapneumovirus
Human rhinovirus/enterovirus
Influenza A virus
Influenza A virus A/H1-2009
Influenza A virus A/H3
Influenza B virus
Parainfluenza virus
Respiratory syncytial virus
Bacteria:
Bordetella parapertussis
Bordetella pertussis
Chlamydia pneumoniae
Mycoplasma pneumoniae
Nucleic acids from the 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 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 an NPS specimen. Positive results do not rule out coinfection with other organisms. The agent(s) detected by the SPOTFIRE R Panel 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 as stated in the FDA summary.
https://510kreport.com/device/K213954 · printed Nov 5, 2026
Cite this page
510(k) Report. “K213954: BIOFIRE SPOTFIRE Respiratory (R) Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K213954
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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