510(k) · Cleared
ClearedQIAstat-Dx Meningitis/Encephalitis (ME) Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
QIAGEN GmbH · PLO Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
Cleared on Oct 29, 2024 as substantially equivalent to K160462 (Biofire Diagnostics, LLC, 2016) after a 90-day review. Its family tree reaches back 2 generations to 2015.
- Decided
- Oct 29, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- PLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN150013 (2015). No later device cites it as a predicate yet.
- Root · 2 generations backDEN150013 FilmArray Meningitis/Encephalitis (ME) PanelBiofire Diagnostics, LLC · 2015
- 1 generation backK160462 FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray…Biofire Diagnostics, LLC · 2016
- This deviceK242256 QIAstat-Dx Meningitis/Encephalitis (ME) PanelQIAGEN GmbH · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN150013 | FilmArray Meningitis/Encephalitis (ME) Panel | Biofire Diagnostics, LLC | 2015 | — |
| −1 | K160462 | FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch | Biofire Diagnostics, LLC | 2016 | — |
| 0 (this device) | K242256 | QIAstat-Dx Meningitis/Encephalitis (ME) Panel | QIAGEN GmbH | 2024 | — |
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 PLO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K160462 | FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray TorchSummary page 5…LO Predicate Device: Manufacturer Product Name De Novo/510(k) No. BioFire Diagnostics, LLC FilmArray K160462 Meningitis/Encephalitis (ME) Panel October 28, 2024 === Page 6 ==… | 2016 |
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 9 years and passes through 2 companies; a new generation was cleared every 8.6 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K160462.
How does its category compare?
All PLO devicesPLO Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · PLO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PLO
Too few PLO 510(k)s in any year since 2007 to give a median.
Recalls per year · PLO
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PLO
4in 2025
MAUDE reports naming product code PLO, 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 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 1 | 3 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (268 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242256: QIAstat-Dx Meningitis/Encephalitis (ME) Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242256
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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