510(k) · Cleared
Clearedillumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Bioscience, Inc. · PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Cleared on Jul 17, 2015 after an 88-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 2 later devices descend from it.
- Decided
- Jul 17, 2015
- Review
- 88 days
- Class
- Class II
- Product code
- PGI
- Recalls
- None
- Predicates
- 1
2 later devices descend from it, 1 citing it directly.
- This deviceK151046 illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2…Meridian Bioscience, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK151906 ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2…Luminex Corporation · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK180559 HSV 1 & 2 ELITe MGB Kit; ELITe InGeniusElitechgroup · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K151046 | illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External… | Meridian Bioscience, Inc. | 2015 | — |
| +1 | K151906 | ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay… | Luminex Corporation | 2015 | 1 |
| +2 | K180559 | HSV 1 & 2 ELITe MGB Kit; ELITe InGenius | Elitechgroup | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K133448 | Quidel Corporation Lyra™ Direct HSV 1 + 2/VZV Assay Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 5…us lesion panel (21 CFR 866.3309, Product Code PGI) Predicate Device: Quidel Corporation Lyra™ Direct HSV 1 + 2/VZV Assay K133448 Page 1… |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151906 | ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File… | 2015 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K151906 (Luminex Corporation, 2015) has gone furthest, with 1 descendant 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?
illumigene® HSV 1&2 DNA Amplification Assay: The illumigene HSV 1&2 DNA amplification assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. illumigene HSV 1&2 utilizes loop-mediated…
Read the full statement (224 words)
illumigene® HSV 1&2 DNA Amplification Assay:
The illumigene HSV 1&2 DNA amplification assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections.
illumigene HSV 1&2 utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect HSV-1 and HSV-2 by targeting segments of the herpes simplex virus 1 and herpes simplex virus 2 genomes. Results from illumigene HSV 1&2 are used as an aid in the diagnosis of HSV infection in symptomatic patients.
The assay is intended for use in hospital, reference or state laboratory settings. This device is not intended for nonlaboratory point-of-care use.
WARNING: illumigene HSV 1&2 is not FDA cleared for use with cerebrospinal fluid (CSF) or to aid in the diagnosis of HSV infections of the central nervous system (CNS). The device is not intended for prenatal screening.
illumigene® HSV 1&2 External Control Kit:
The illumigene HSV 1&2 External Control Kit contains Positive and Negative Control Reagents for use with the illumigene HSV 1&2 DNA Amplification Assay. External controls are used as part of a routine quality control program to aid the user in detection of unexpected conditions that may lead to test errors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151046 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151046: illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151046
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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