# K230956: BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System

- Pathway: 510(k) (Traditional)
- Applicant: Bd Integrated Diagnostic Solutions /
- Decided: Jul 31, 2023 after 118 days
- Product code: QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents)
- Device class: 2
- Regulation: 21 CFR 866.3981
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN200031 (2021). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN200031: BioFire Respiratory Panel 2.1 (RP2.1), Biofire Diagnostics, LLC (2021) Summary page 6.
- K211079: BioFire COVID-19 Test 2, Biofire Defense, LLC (2021) Summary page 9.
- K221460: BioFire COVID-19 Test 2, Biofire Defense, LLC (2022) Summary page 9.

## Indications for use
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.

Source page: https://510kreport.com/device/K230956
Methodology: https://510kreport.com/methodology