De Novo · Granted
GrantedFilmArray Meningitis/Encephalitis (ME) Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofire Diagnostics, LLC · PLO Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
Granted on Oct 8, 2015 as a new device type through De Novo after a 182-day review. 3 later devices descend from it.
- Decided
- Oct 8, 2015
- Review
- 182 days
- Class
- Class II
- Product code
- PLO
- Recalls
- None
3 later devices descend from it, 1 citing it directly.
- This deviceDEN150013 FilmArray Meningitis/Encephalitis (ME) PanelBiofire Diagnostics, LLC · 2015
- Descendant · cites it directly · 2 of its ownK160462 FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray…Biofire Diagnostics, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK242256 QIAstat-Dx Meningitis/Encephalitis (ME) PanelQIAGEN GmbH · 2024
- Descendant · 2 generations on · 0 of its ownK190219 Simplexa VZV Direct, Simplexa VZV Positive Control PackDiasorin Molecular, LLC · 2019 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K160462FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray TorchBiofire Diagnostics, LLC · 2016 · cites it directly2descendants
- K242256QIAstat-Dx Meningitis/Encephalitis (ME) PanelQIAGEN GmbH · 2024 · 2 generations on0descendants
- K190219Simplexa VZV Direct, Simplexa VZV Positive Control PackDiasorin Molecular, LLC · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K242256 | QIAstat-Dx Meningitis/Encephalitis (ME) Panel | QIAGEN GmbH | 2024 | — |
| +2 | K190219 | Simplexa VZV Direct, Simplexa VZV Positive Control Pack | Diasorin Molecular, LLC | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA De Novo 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.
Top candidate predicates for a new PLO device
- #1 K242256 QIAstat-Dx Meningitis/Encephalitis (ME) Panelscore 8.6 · 2 generations · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160462 | FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch | 2016 | 2 |
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?
- Of its descendants, K160462 (Biofire Diagnostics, LLC, 2016) has gone furthest, with 2 descendants of its own.
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. 2015, 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 FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray and FilmArray 2.0 systems. The FilmArray ME Panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids directly from cerebrospinal fluid (CSF) specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or…
Read the full statement (273 words)
The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray and FilmArray 2.0 systems. The FilmArray ME Panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids directly 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 FilmArray ME Panel:
Bacteria:
Escherichia coli K1
Haemophilus influenzae
Listeria monocytogenes
Neisseria meningitidis (encapsulated)
Streptococcus agalactiae
Streptococcus pneumoniae
Viruses:
Cytomegalovirus
Enterovirus
Herpes simplex virus 1
Herpes simplex virus 2
Human herpesvirus 6
Human parechovirus
Varicella zoster virus
Yeast:
Cryptococcus neoformans/gattii
The FilmArray ME Panel is indicated as an aid in the diagnosis of specific agents of meningitis and/or encephalitis and results are meant to be used in conjunction with other clinical, epidemiological, and laboratory data.
Results from the FilmArray 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 FilmArray ME Panel. The agent detected may not be the definite cause of the disease. Negative results do not preclude central nervous system (CNS) infection. Not all agents of CNS infection are detected by this test and sensitivity in clinical use may differ from that described in the package insert.
The FilmArray ME Panel is not intended for testing of specimens collected from indwelling CNS medical devices.
The FilmArray ME Panel is intended to be used in conjunction with standard of care culture for organism recovery, serotyping, and antimicrobial susceptibility testing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN150013 · printed Nov 5, 2026
Cite this page
510(k) Report. “DEN150013: FilmArray Meningitis/Encephalitis (ME) Panel.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/DEN150013
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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