# K250080: QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini

- Pathway: 510(k) (Traditional)
- Applicant: QIAGEN GmbH
- Decided: Aug 27, 2025 after 226 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)
- K233100: QIAstat-Dx® Respiratory Panel Plus, QIAGEN GmbH (2024) Summary page 6.
- K242353: QIAstat-Dx Respiratory Panel Mini, QIAGEN GmbH (2024) Summary page 6.

## Indications for use
QIAstat-Dx Respiratory Panel Plus: The QIAstat-Dx Respiratory Panel Plus is a multiplexed nucleic acid test intended for use with the QIAstat-Dx system for the simultaneous in vitro qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals with clinical signs and symptoms of respiratory tract infections, including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The following organism types and subtypes are identified using the QIAstat-Dx Respiratory Panel Plus: Adenovirus, Human Coronavirus 229E, Human Coronavirus HKU1, Human Coronavirus NL63, Human Coronavirus OC43, Human Metapneumovirus, Influenza A, Influenza A H1, Influenza A H1N1 pdm09, Influenza A H3, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Respiratory Syncytial Virus, Human Rhinovirus/Enterovirus (not differentiated), SARS-CoV-2, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. Nucleic acids from viral and bacterial organisms identified by this test are generally detectable in NPS specimens during the acute phase of infection. Detecting and identifying specific viral and bacterial nucleic acids from individuals presenting with signs and symptoms of a respiratory infection aids in the diagnosis of respiratory infection, if used in conjunction with other clinical, epidemiological 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 presence of a respiratory illness may be due to infection with pathogens that are not detected by the test, or due to lower respiratory tract infection that is not detected by a NPS specimen. Conversely, positive results are indicative of the presence of the identified microorganism, but do not rule out co-infection with other pathogens not detected by the QIAstat-Dx Respiratory Panel Plus. The agent(s) detected by the QIAstat-Dx Respiratory Panel Plus may not be the definite cause of disease. The use of additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection. QIAstat-Dx Respiratory Panel Mini: The QIAstat-Dx Respiratory Panel Mini is a multiplexed nucleic acid test intended for use with the QIAstat-Dx system for the simultaneous in vitro qualitative detection and identification of multiple respiratory viral nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals with clinical signs and symptoms of respiratory tract infections, including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The following viruses are identified using the QIAstat-Dx Respiratory Panel Mini: Influenza A, Influenza B, Respiratory Syncytial Virus, Human Rhinovirus, and SARS-CoV-2. Nucleic acids from viral organisms identified by this test are generally detectable in NPS specimens during the acute phase of infection. Detecting and identifying specific viral nucleic acids from individuals presenting with signs and symptoms of a respiratory infection aids in the diagnosis of respiratory infection, if used in conjunction with other clinical, epidemiological 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 presence of a respiratory illness may be due to infection with pathogens that are not detected by the test or due to lower respiratory tract infection that is not detected by a NPS specimen. Conversely, positive results are indicative of the presence of the identified microorganism, but do not rule out co-infection with other pathogens not detected by the QIAstat-Dx Respiratory Panel Mini. The agent(s) detected by the QIAstat-Dx Respiratory Panel Mini may not be the definite cause of disease. The use of additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection.

Source page: https://510kreport.com/device/K250080
Methodology: https://510kreport.com/methodology