# K233100: QIAstat-Dx® Respiratory Panel Plus

- Pathway: 510(k) (Traditional)
- Applicant: QIAGEN GmbH
- Decided: May 10, 2024 after 227 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN200031 (2021). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 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.

## Most influential descendants
- K242353: QIAstat-Dx Respiratory Panel Mini (2024), 1 descendant of its own
- K261336: Xpert Respiratory Panel (2026), 0 descendants of its own
- K250080: QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini (2025), 0 descendants of its own

## Recalls of this device
- Mar 12, 2025 · Class II · Z-1504-2025: Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.

## Indications for use
The QlAstat-Dx Respiratory Panel Plus is a multiplexed nucleic acid test intended for use with the QlAstat-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 infection, including SARS-CoV-2. The following organism types and subtypes are identified using the QLAstat-Dx Respiratory Panel Plus: Adenovirus, Human Coronavirus 229E, Human Coronavirus HKUl, Human Coronavirus NL63, Human Coronavirus OC43, Human Metapneumovirus, Influenza A, Influenza A Hi, 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), Severe Acute Respiratory Syndrome Coronavirus (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.

Source page: https://510kreport.com/device/K233100
Methodology: https://510kreport.com/methodology