510(k) · Cleared
Recalled · Class II · 2020Simplexa VZV Swab 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 · PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Cleared on Nov 26, 2019 as substantially equivalent to K162451 (Quidel Corporation, 2016) after an 88-day review. Its family tree reaches back 1 generation to 2016. It has been recalled once.
- Decided
- Nov 26, 2019
- Review
- 88 days
- Class
- Class II
- Product code
- PGI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K162451 (2016). No later device cites it as a predicate yet.
- Root · 1 generation backK162451 Solana HSV 1+2/VZV AssayQuidel Corporation · 2016
- This deviceK192376 Simplexa VZV Swab 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 |
|---|---|---|---|---|---|
| −1 | K162451 | Solana HSV 1+2/VZV Assay | Quidel Corporation | 2016 | — |
| 0 (this device) | K192376 | Simplexa VZV Swab 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 PGI? 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 PGI device
- #1 K232286 Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV…score 6.5 · 1 generation · 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 |
|---|---|---|---|
| * | K162451 | Solana HSV 1+2/VZV AssaySummary page 3…acid amplification (NAT) assays 21 CFR § 866.3920 Classification Class II Predicate Device Solana® HSV 1+2/VZV Assay (K162451) Intended Use Simplexa™ VZV Direct The DiaSorin Molecular Simplexa™ VZV Swab Direct assay is intended for use on the LIAISON®… | 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-2549-2020 | 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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K162451.
How does its category compare?
All PGI devicesPGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · PGI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PGI
Too few PGI 510(k)s in any year since 2007 to give a median.
Recalls per year · PGI
No recall names PGI since 2007.
Adverse event reports per year · PGI
36in 2025
MAUDE reports naming product code PGI, 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 | 1 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 36 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DiaSorin Molecular Simplexa™ VZV Swab Direct assay is intended for use on the LIAISON® MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA present in cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of VZV infection. This test is intended as an aid in the diagnosis of VZV infection. Negative results do not preclude VZV infection and should not be used as the sole basis for treatment or other…
Read the full statement (121 words)
The DiaSorin Molecular Simplexa™ VZV Swab Direct assay is intended for use on the LIAISON® MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA present in cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of VZV infection. This test is intended as an aid in the diagnosis of VZV infection. Negative results do not preclude VZV infection and should not be used as the sole basis for treatment or other patient management decisions.
The Simplexa™ VZV Positive Control Pack is intended to be used as a control with the Simplexa™ VZV Direct kit and the Simplexa™ VZV Swab Direct kit on the LIAISON® MDX Instrument. It is not intended for use with other assays or systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192376 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192376: Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192376
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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