Biofire Diagnostics, LLC: FDA clearances and approvals
Biofire Diagnostics, LLC has 31 FDA 510(k) clearances (first 2013, latest 2025), plus 4 De Novo decisions, across 13 product codes in 2 review panels. Median 510(k) review time: 73 days. Since 2017 its median was 74 days, against 114 days for all cleared 510(k)s in the same product codes. openFDA lists 44 product recalls by a recalling firm named Biofire Diagnostics, LLC. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 5 | 49 |
| 2014 | 1 | 73 |
| 2015 | 4 | 100 |
| 2016 | 5 | 27 |
| 2017 | 1 | 90 |
| 2018 | 3 | 181 |
| 2019 | 0 | — |
| 2020 | 1 | 90 |
| 2021 | 1 | 26 |
| 2022 | 1 | 59 |
| 2023 | 3 | 29 |
| 2024 | 4 | 60 |
| 2025 | 2 | 150 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Biofire Diagnostics, LLC's cleared 510(k)s took a median 74 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 6 | 6 |
| PEN | Gram-Negative Bacteria And Associated Resistance Markers | 6 | 6 |
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 6 | 5 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 5 | 5 |
| PLO | Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System | 2 | 1 |
| QDP | Respiratory Panel | 2 | 2 |
| QDS | Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System | 2 | 2 |
| NHT | Assay, Nucleic Acid Amplification, Bacillus Anthracis | 1 | 1 |
| NSU | Instrumentation For Clinical Multiplex Test Systems | 1 | 1 |
| OEH | Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit | 1 | 1 |
Plus 3 more product codes.
Review panels
- Microbiology (34)
- Clinical Chemistry (1)
Most recent Biofire Diagnostics, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243544 | BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini | QOF | 2025-08-14 | 272 |
| K243885 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid | PCH | 2025-01-16 | 29 |
| K243759 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) | PEN | 2024-12-20 | 14 |
| K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | PCH | 2024-11-07 | 90 |
| K241194 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini | QOF | 2024-05-30 | 30 |
| K232954 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel | QOF | 2024-03-26 | 187 |
| K230719 | BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini | QOF | 2023-04-13 | 29 |
| K230404 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | PCH | 2023-03-16 | 29 |
| K213954 | BIOFIRE SPOTFIRE Respiratory (R) Panel | QOF | 2023-02-03 | 413 |
| K222601 | FilmArray Pneumonia Panel plus | QDS | 2022-10-27 | 59 |
21 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200066 | De Novo | Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System | 2022-04-29 |
| DEN200031 | De Novo | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 2021-03-17 |
| DEN170017 | De Novo | Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System | 2017-11-24 |
| DEN150013 | De Novo | Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System | 2015-10-08 |
Recalls
44 product recalls in 34 recall events; 28 initiated in the last five years. Most recent: 2026-06-24.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Biofire Diagnostics, LLC is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03029299: Implementation Assessment and Clinical Utility of the FilmArray® Respiratory Panel (RP) EZ in a CLIA-waived Setting (Completed, started 2017-04-04)
- NCT02248285: Implementation of a Molecular Diagnostic for Pediatric Acute Gastroenteritis: The FilmArray GI Panel IMPACT Study (Completed, started 2015-04)
Frequently asked questions
How many FDA 510(k) clearances does Biofire Diagnostics, LLC have?
Biofire Diagnostics, LLC has 31 FDA 510(k) clearances (first 2013, latest 2025), plus 4 De Novo decisions, across 13 product codes in 2 review panels.
How long does FDA take to clear Biofire Diagnostics, LLC's 510(k)s?
The median time from FDA receipt to decision across Biofire Diagnostics, LLC's cleared 510(k)s is 73 days. Since 2017: 74 days, versus 114 days for all cleared 510(k)s in the same product codes.
What devices does Biofire Diagnostics, LLC make?
Its most frequent FDA product codes are PCH (Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System, 6); PEN (Gram-Negative Bacteria And Associated Resistance Markers, 6); QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents, 6).
Has Biofire Diagnostics, LLC had device recalls?
openFDA lists 44 product recalls in 34 recall events by a recalling firm whose name matches Biofire Diagnostics, LLC; the most recent began 2026-06-24. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 31 Biofire Diagnostics, LLC clearances with predicates and recalls
- Run predicate analysis for product code PCH, Biofire Diagnostics, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.