510(k) · Cleared
ClearedBIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini
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
Cleared on Aug 14, 2025 as substantially equivalent to K241194 (Biofire Diagnostics, LLC, 2024) after a 272-day review. Its family tree reaches back 4 generations to 2021.
- Decided
- Aug 14, 2025
- Review
- 272 days
- Class
- Class II
- Product code
- QOF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN200031 (2021). No later device cites it as a predicate yet.
- Root · 4 generations backDEN200031 BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC · 2021
- 3 generations backK213954 BIOFIRE SPOTFIRE Respiratory (R) PanelBiofire Diagnostics · 2023
- 2 generations backK232954 BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) PanelBiofire Diagnostics, LLC · 2024 · Recalled
- 1 generation backK241194 BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel MiniBiofire Diagnostics, LLC · 2024
- This deviceK243544 BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniBiofire Diagnostics, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN200031 | BioFire Respiratory Panel 2.1 (RP2.1) | Biofire Diagnostics, LLC | 2021 | — |
| −3 | K213954 | BIOFIRE SPOTFIRE Respiratory (R) Panel | Biofire Diagnostics | 2023 | — |
| −2 | K232954 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel | Biofire Diagnostics, LLC | 2024 | 1 |
| −1 | K241194 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini | Biofire Diagnostics, LLC | 2024 | — |
| 0 (this device) | K243544 | BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini | Biofire Diagnostics, LLC | 2025 | — |
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 |
|---|---|---|---|
| * | K241194 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel MiniSummary page 6…866.3981 Classification Name: Multi-Target Respiratory Specimen Nucleic Acid Test Including SARS-CoV-2 And Other Microbial Agents Product Code: QOF Predicate Device: K241194 – BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini… | 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 4 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
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. 2025, 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/Sore Throat (R/ST) Panel Mini is an automated 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) or anterior nasal swab (ANS) specimens obtained from individuals with signs and symptoms of respiratory tract infection, including…
Read the full statement (321 words)
The BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini is an automated 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) or anterior nasal
swab (ANS) specimens obtained from individuals with signs and symptoms of respiratory tract infection, including
COVID-19; (Respiratory menu) or in throat swab (TS) specimens from individuals with signs and symptoms of
pharyngitis; (Sore Throat menu).
The following analytes are identified and differentiated using the BIOFIRE SPOTFIRE R/ST Panel Mini:
Respiratory Menu
Viruses
Coronavirus SARS-CoV-2
Human rhinovirus
Influenza A virus
Influenza B virus
Respiratory syncytial virus
Sore Throat Menu
Viruses
Human rhinovirus
Influenza A virus
Influenza B virus
Respiratory syncytial virus
Bacteria
Streptococcus pyogenes (group A Strep)
Nucleic acids from the viral and bacterial organisms identified by this test are generally detectable in NPS/ANS/TS
specimens during the acute phase of infection. The detection and identification of specific viral and bacterial nucleic acids
from individuals exhibiting signs and symptoms of respiratory infection and/or pharyngitis is 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 and/or pharyngitis may be due to infection with pathogens that are
not detected by this test, or a respiratory tract infection that may not be detected by an NPS, ANS, or TS specimen.
Positive results do not rule out co-infection with other organisms. The agent(s) detected by the BIOFIRE SPOTFIRE
R/ST Panel Mini 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 and/or pharyngitis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243544 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243544: BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243544
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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