510(k) · Cleared
Recalled · Class II · 2020Simplexa VZV Direct, Simplexa VZV Positive Control Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diasorin Molecular, LLC · PLO Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
Cleared on May 13, 2019 as substantially equivalent to K160462 (Biofire Diagnostics, LLC, 2016) after a 98-day review. Its family tree reaches back 2 generations to 2015. It has been recalled once.
- Decided
- May 13, 2019
- Review
- 98 days
- Class
- Class II
- Product code
- PLO
- Recalls
- 1
- 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 deviceK190219 Simplexa VZV Direct, Simplexa VZV Positive Control PackDiasorin Molecular, LLC · 2019
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) | K190219 | Simplexa VZV Direct, Simplexa VZV Positive Control Pack | Diasorin Molecular, LLC | 2019 | — |
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.
Top candidate predicates for a new PLO device
- #1 K242256 QIAstat-Dx Meningitis/Encephalitis (ME) Panelscore 8.6 · 2 generations · no Class I recall
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 4…862.2570 Classification Class II Predicate Devices BioFire® FilmArray® Meningitis/Encephalitis (ME) Panel K160462 Intended Use Simplexa™ VZV Direct REF MOL3650 The DiaSorin Molecular Simplexa™ VZV Direct assay is intended for use on the LIAIS… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 12, 2020 | Class II | Z-2548-2020 | Under Investigation by firm | Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.2 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. 2019, 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 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190219 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190219: Simplexa VZV Direct, Simplexa VZV Positive Control Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190219
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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