# K242256: QIAstat-Dx Meningitis/Encephalitis (ME) Panel

- Pathway: 510(k) (Traditional)
- Applicant: QIAGEN GmbH
- Decided: Oct 29, 2024 after 90 days
- Product code: PLO (Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System)
- Device class: 2
- Regulation: 21 CFR 866.3970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN150013 (2015). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160462: FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch, Biofire Diagnostics, LLC (2016) Summary page 5.

## Indications for use
The QIAstat-Dx Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid real-time PCR based in vitro diagnostic test intended for use with the QIAstat-Dx Analyzer 1.0. The QIAstat-Dx ME Panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids from cerebrospinal fluid (CSF) specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or encephalitis. The following organisms are identified using the QIAstat-Dx ME Panel: Enterovirus, Escherichia coli K1, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitidis (encapsulated), Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, and Cryptococcus neoformans/gattii*. The QIAstat-Dx ME Panel is indicated as an aid in the diagnosis of specific agents of meningitis and/or encephalitis and results must be used in conjunction with other clinical, epidemiological, and laboratory data. Results from the QIAstat-Dx ME Panel are not intended to be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with organisms not included in the QIAstat-Dx ME Panel. The agent or agents detected may not be the definite cause of the disease. Negative results do not preclude central nervous system infection. Not all agents of central nervous system infection are detected by this test and sensitivity in clinical use may differ from that described in the instructions for use. The QIAstat-Dx ME Panel is not intended for testing specimens collected from indwelling central nervous system medical devices. The QIAstat-Dx ME Panel is intended to be used in conjunction with standard of care culture for organism recovery, serotyping, and antimicrobial susceptibility testing. *Cryptococcus neoformans and Cryptococcus gattii are not differentiated.

Source page: https://510kreport.com/device/K242256
Methodology: https://510kreport.com/methodology