510(k) · Cleared
ClearedEuroimmun Anti-HSV-2 Elisa (Igg) and Anti-HSV-1 Elisa (Igg) Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Euroimmun Us, LLC · MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Cleared on Jun 28, 2007 after a 421-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 28, 2007
- Review
- 421 days
- Class
- Class II
- Product code
- MYF
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MYF? 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 MYF device
- #1 K243575 ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG…score 8.8 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All MYF devicesMYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MYF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MYF
Too few MYF 510(k)s in any year since 2007 to give a median.
Recalls per year · MYF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MYF
43in 2025
MAUDE reports naming product code MYF, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 252 |
| 2024 | 0 | — | 0 | 13 |
| 2025 | 1 | — | 0 | 43 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EUROIMMUN Anti-HSV-1 ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against Herpes simplex virus type 1 (HSV-1) specific glycoprotein C1 in human serum. It is intended for the presumptive diagnosis of type specific HSV-1 infection in conjunction with EUROIMMUN Anti-HSV-2 ELISA (IgG) in persons suspected of herpes viral infection. The EUROIMMUN Anti-HSV-2 ELISA (IgG) is intended for the qualitative determination of…
Read the full statement (108 words)
The EUROIMMUN Anti-HSV-1 ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against Herpes simplex virus type 1 (HSV-1) specific glycoprotein C1 in human serum. It is intended for the presumptive diagnosis of type specific HSV-1 infection in conjunction with EUROIMMUN Anti-HSV-2 ELISA (IgG) in persons suspected of herpes viral infection.
The EUROIMMUN Anti-HSV-2 ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against herpes simplex virus type 2 (HSV-2) specific glycoprotein G2 in human serum. It is intended for the presumptive diagnosis of type specific HSV-2 infection in conjunction with EUROIMMUN Anti-HSV-1 ELISA (IgG) in persons suspected of herpes viral infection.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K061239 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061239: Euroimmun Anti-HSV-2 Elisa (Igg) and Anti-HSV-1 Elisa (Igg) Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061239
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026