510(k) · Cleared
Recalled · Class II · 2019ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Luminex Corporation · PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Cleared on Oct 6, 2015 as substantially equivalent to K151046 (Meridian Bioscience, Inc., 2015) after an 85-day review. Its family tree reaches back 1 generation to 2015. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 6, 2015
- Review
- 85 days
- Class
- Class II
- Product code
- PGI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K151046 (2015). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK151046 illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2…Meridian Bioscience, Inc. · 2015
- This deviceK151906 ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2…Luminex Corporation · 2015
- Descendant · cites it directly · 0 of its ownK180559 HSV 1 & 2 ELITe MGB Kit; ELITe InGeniusElitechgroup · 2018
Most influential descendants
Showing 1 of 1 · See all- K180559HSV 1 & 2 ELITe MGB Kit; ELITe InGeniusElitechgroup · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K151046 | illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External… | Meridian Bioscience, Inc. | 2015 | — |
| 0 (this device) | K151906 | ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay… | Luminex Corporation | 2015 | — |
| +1 | K180559 | HSV 1 & 2 ELITe MGB Kit; ELITe InGenius | Elitechgroup | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
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 |
|---|---|---|---|
| * | K151046 | illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit… Cleared while this submission was under review Summary page 6…ubstantial Equivalence Information: a. Predicate device name(s): illumigene® HSV 1&2 DNA Amplification Assay (Meridian Bioscience, Inc.) b. Predicate 510(k) number(s): K151046 Confidential & Restricted Executive Summary Page 3 of 17… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180559 | HSV 1 & 2 ELITe MGB Kit; ELITe InGenius | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 20, 2019 | Class II | Z-2283-2019 | Process control | Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K180559 (Elitechgroup, 2018) has gone furthest, with 0 descendants of its own.
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. 2015, 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 ARIES® HSV 1&2 Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV 1 and HSV 2) DNA in cutaneous or mucocutaneous lesion specimens from symptomatic patients. The test is indicated for use as an aid in diagnosis of HSV infection in symptomatic patients. The ARIES® HSV 1&2 Assay is indicated for use on the ARIES® System.
WARNING: The ARIES® HSV 1&2 Assay is not FDA cleared for use with cerebrospinal fluid (CSF). The assay is not intended to be used for prenatal screening.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151906 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151906: ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151906
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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