510(k) · Cleared
ClearedBD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Integrated Diagnostic Solutions / · QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Cleared on Jul 31, 2023 as substantially equivalent to DEN200031 (Biofire Diagnostics, LLC, 2021) and 2 other predicates after a 118-day review. Its family tree reaches back 3 generations to 2021.
- Decided
- Jul 31, 2023
- Review
- 118 days
- Class
- Class II
- Product code
- QOF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to DEN200031 (2021). No later device cites it as a predicate yet.
- Root · 3 generations backDEN200031 BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC · 2021
- 2 generations backK211079 BioFire COVID-19 Test 2Biofire Defense, LLC · 2021
- 1 generation backK221460 BioFire COVID-19 Test 2Biofire Defense, LLC · 2022
- This deviceK230956 BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral…Bd Integrated Diagnostic Solutions / · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN200031 | BioFire Respiratory Panel 2.1 (RP2.1) | Biofire Diagnostics, LLC | 2021 | — |
| −2 | K211079 | BioFire COVID-19 Test 2 | Biofire Defense, LLC | 2021 | — |
| −1 | K221460 | BioFire COVID-19 Test 2 | Biofire Defense, LLC | 2022 | — |
| 0 (this device) | K230956 | BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2… | Bd Integrated Diagnostic Solutions / | 2023 | — |
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? (3)
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 6…d Test Including SARS-CoV-2 And Other Microbial Agents QQX – Respiratory Specimen Nucleic Acid SARS-CoV-2 Test Predicate Device BioFire Respiratory Panel 2.1 (RP2.1) (DEN200031) Device Establishment Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 Registration Number: 1119779 Performance… | 2021 |
| * | K211079 | BioFire COVID-19 Test 2Summary page 9…included in the BioFire Respiratory Panel 2.1 (RP2.1). The BD Respiratory Viral Panel-SCV2 for BD MAX™ System has the same analyte target as the BioFire COVID-19 Test 2, K211079/K221460. Technological Comparison: The BD MAX™ Assays have similar principle of operation as their predicate, the BioFire Respi… | 2021 |
| * | K221460 | BioFire COVID-19 Test 2Summary page 9…in the BioFire Respiratory Panel 2.1 (RP2.1). The BD Respiratory Viral Panel-SCV2 for BD MAX™ System has the same analyte target as the BioFire COVID-19 Test 2, K211079/K221460. Technological Comparison: The BD MAX™ Assays have similar principle of operation as their predicate, the BioFire Respiratory P… | 2022 |
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 2 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- None of the 3 ancestors has a recall.
- 12 other devices also cite its predicate DEN200031.
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?
BD Respiratory Viral Panel for BD MAX™ System: BD Respiratory Viral Panel for BD MAX™ System is an automated multiplexed real-time reverse transcriptase polymerase chain reaction (RT- PCR) test intended for the simultaneous, qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, influenza B, and/or respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swab (NPS) and anterior…
Read the full statement (400 words)
BD Respiratory Viral Panel for BD MAX™ System:
BD Respiratory Viral Panel for BD MAX™ System is an automated multiplexed real-time reverse transcriptase polymerase chain reaction (RT- PCR) test intended for the simultaneous, qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, influenza B, and/or respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swab (NPS) and anterior nasal swab (ANS) specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2, influenza, and RSV can be similar.
BD Respiratory Viral Panel for BD MAX™ System is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, influenza B, and/or RSV infection if used in conjunction with other clinical and epidemiological information, and laboratory findings. SARS-CoV- 2, influenza A, influenza B, and RSV viral nucleic acid are generally detectable in NPS and ANS specimens during the acute phase of infection.
Positive results do not rule out co-infection with other organisms. The agent(s) detected by the BD Respiratory Viral Panel for BD MAX™ System may not be the definitive cause of disease.
Negative results do not preclude SARS-CoV-2, influenza A, influenza B, and/or RSV infection.
The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
BD Respiratory Viral Panel-SCV2 for BD MAX™ System:
BD Respiratory Viral Panel-SCV2 for BD MAX™ System is an automated multiplexed real-time reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the simultaneous, qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral nucleic acid in nasopharyngeal swab (NPS) and anterior nasal swab (ANS) specimens from individuals with signs and symptoms of respiratory tract infection. SARS-CoV-2 viral RNA is generally detectable in NPS and ANS specimens during the acute phase of infection.
The BD Respiratory Viral Panel-SCV2 for BD MAX™ System is intended for use as an aid in the diagnosis of SARS-CoV-2 infection if used in conjunction with other clinical and epidemiological information, and laboratory findings.
Positive results do not rule out co-infection with other organisms. The agent detected by the BD Respiratory Viral Panel-SCV2 for BD MAX™ System may not be the definitive cause of disease.
Negative results do not preclude SARS-CoV-2 infection.
The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
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/K230956 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230956: BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230956
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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