510(k) · Cleared
Recalled · Class II · 2026BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel
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 Mar 26, 2024 as substantially equivalent to K213954 (Biofire Diagnostics, 2023) after a 187-day review. Its family tree reaches back 2 generations to 2021. 2 later devices descend from it. It has been recalled once.
- Decided
- Mar 26, 2024
- Review
- 187 days
- Class
- Class II
- Product code
- QOF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN200031 (2021). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN200031 BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC · 2021
- 1 generation backK213954 BIOFIRE SPOTFIRE Respiratory (R) PanelBiofire Diagnostics · 2023
- This deviceK232954 BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) PanelBiofire Diagnostics, LLC · 2024
- Descendant · cites it directly · 1 of its ownK241194 BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel MiniBiofire Diagnostics, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK243544 BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniBiofire Diagnostics, LLC · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN200031 | BioFire Respiratory Panel 2.1 (RP2.1) | Biofire Diagnostics, LLC | 2021 | — |
| −1 | K213954 | BIOFIRE SPOTFIRE Respiratory (R) Panel | Biofire Diagnostics | 2023 | — |
| 0 (this device) | K232954 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel | Biofire Diagnostics, LLC | 2024 | — |
| +1 | K241194 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini | Biofire Diagnostics, LLC | 2024 | — |
| +2 | K243544 | BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini | Biofire Diagnostics, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K213954 | BIOFIRE SPOTFIRE Respiratory (R) PanelSummary page 5…el is compatible with the BIOFIRE® SPOTFIRE® System (SPOTFIRE System), a polymerase chain reaction (PCR)-based in vitro diagnostic system for infectious disease testing (K213954/ CW210006). According to the requirements of 21 CFR 807.92, the information included with this submission provides sufficient de… | 2023 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241194 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini | 2024 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 1, 2026 | Class II | Z-2081-2026 | Under Investigation by firm | Respiratory/sore throat panel test may result in false negative results and control failures. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K241194 (Biofire Diagnostics, LLC, 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K213954.
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 BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) 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; (Respiratory menu) or in…
Read the full statement (357 words)
The BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) 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; (Respiratory menu) or in throat swab (TS) specimens from individuals with signs and symptoms of pharyngitis (Sore Throat menu).
The following organism types and subtypes are identified and differentiated using the SPOTFIRE R/ST Panel:
Respiratory Menu Sore Throat Menu
Viruses Viruses
Adenovirus Adenovirus
Coronavirus SARS-CoV-2 Coronavirus (seasonal)
Coronavirus (seasonal) Human metapneumovirus
Human metapneumovirus Human rhinovirus/enterovirus
Human rhinovirus/enterovirus Influenza A virus
Influenza A virus Influenza A virus/H1-2009
Influenza A virus/H1-2009 Influenza A virus/H3
Influenza A virus/ H3 Influenza B virus
Influenza B virus Parainfluenza virus
Parainfluenza virus Respiratory syncytial virus
Respiratory syncytial virus
Bacteria Bacteria
Bordetella parapertussis Chlamydia pneumoniae
Bordetella pertussis Mycoplasma pneumoniae
Chlamydia pneumoniae Streptococcus dysgalactiae (Group C/G Strep)
Mycoplasma pneumoniae Streptococcus pyogenes (Group A Strep)
Nucleic acids from the viral and bacterial organisms identified by this test are generally detectable in NPS/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 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 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 or TS specimen. Positive results do not rule out coinfection with other organisms. The agent(s) detected by the SPOTFIRE R/ST 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 and/or pharyngitis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232954 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232954: BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232954
Report an extraction error
Are you the manufacturer?
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