510(k) · Cleared
ClearedHSV 1 & 2 ELITe MGB Kit; ELITe InGenius
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elitechgroup · PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Cleared on Oct 29, 2018 as substantially equivalent to K151906 (Luminex Corporation, 2015) after a 242-day review. Its family tree reaches back 2 generations to 2015.
- Decided
- Oct 29, 2018
- Review
- 242 days
- Class
- Class II
- Product code
- PGI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K151046 (2015). No later device cites it as a predicate yet.
- Root · 2 generations backK151046 illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2…Meridian Bioscience, Inc. · 2015
- 1 generation backK151906 ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2…Luminex Corporation · 2015 · Recalled
- This deviceK180559 HSV 1 & 2 ELITe MGB Kit; ELITe InGeniusElitechgroup · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 |
| 0 (this device) | K180559 | HSV 1 & 2 ELITe MGB Kit; ELITe InGenius | Elitechgroup | 2018 | — |
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 |
|---|---|---|---|
| * | K151906 | ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File…Summary page 4…1&2 ELITe MBG Assay Class II PGI 21CFR 866.3309 5. Predicate Devices: K151906 LUMINEX Corporation ARIES® HSV 1&2 Assay Section 5 – 510(k) Summa… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
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. 2018, 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 HSV 1&2 ELITe MGB® 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 swab specimens from patients with signs and symptoms of HSV-1 or HSV-2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections.
The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180559: HSV 1 & 2 ELITe MGB Kit; ELITe InGenius.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180559
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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