# K190219: Simplexa VZV Direct, Simplexa VZV Positive Control Pack

- Pathway: 510(k) (Traditional)
- Applicant: Diasorin Molecular, LLC
- Decided: May 13, 2019 after 98 days
- Product code: PLO (Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System)
- Device class: 2
- Regulation: 21 CFR 866.3970
- 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: 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 4.

## Recalls of this device
- May 12, 2020 · Class II · Z-2548-2020: Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.

## Indications for use
The DiaSorin Molecular Simplexa™ VZV Direct assay is intended for use on the LIAISON® MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA in cerebrospinal fluid (CSF) from patients signs and/or symptoms of meningitis and/or encephalitis. This test is intended as an aid in the diagnosis of VZV infections of the central nervous system (CNS). Negative results do not preclude VZV infection and should not be used as the sole basis for treatment or other patient management decisions. The assay is not intended for use as a donor screening test. The assay is for professional use only.

Source page: https://510kreport.com/device/K190219
Methodology: https://510kreport.com/methodology