# K160462: FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch

- Pathway: 510(k) (Special)
- Applicant: Biofire Diagnostics, LLC
- Decided: Mar 17, 2016 after 27 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: 1 generation back to DEN150013 (2015). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN150013: FilmArray Meningitis/Encephalitis (ME) Panel, Biofire Diagnostics, LLC (2015) Summary page 5.

## Most influential descendants
- K242256: QIAstat-Dx Meningitis/Encephalitis (ME) Panel (2024), 0 descendants of its own
- K190219: Simplexa VZV Direct, Simplexa VZV Positive Control Pack (2019), 0 descendants of its own

## Indications for use
The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray, FilmArray 2.0, and FilmArray Torch 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.

Source page: https://510kreport.com/device/K160462
Methodology: https://510kreport.com/methodology