510(k) · Cleared
ClearedHSV-2 Elisa Igg, Model EL0920G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mrl Diagnostics · MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Cleared on Feb 1, 2000 after a 90-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Feb 1, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- MYF
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK993724 HSV-2 Elisa Igg, Model EL0920GMrl Diagnostics · 2000
- Descendant · cites it directly · 3 of its ownK031952 West Nile Virus Igm Capture Elisa, Model EL0300MFocus Technologies, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK040854 West Nile Virus Igm Capture ElisaFocus Technologies, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK031953 West Nile Virus Elisa Igg, Model EL0300GFocus Technologies, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 0 of its ownK153308 EUROIMMUN Anti-West Nile Virus ELISA (IgM)Euroimmun Us, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK153303 EUROIMMUN Anti-West Nile Virus ELISA (IgG)Euroimmun Us, Inc. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K031952West Nile Virus Igm Capture Elisa, Model EL0300MFocus Technologies, Inc. · 2003 · cites it directly3descendants
- K040854West Nile Virus Igm Capture ElisaFocus Technologies, Inc. · 2004 · cites it directly1descendant
- K031953West Nile Virus Elisa Igg, Model EL0300GFocus Technologies, Inc. · 2003 · cites it directly1descendant
- K153308EUROIMMUN Anti-West Nile Virus ELISA (IgM)Euroimmun Us, Inc. · 2016 · 2 generations on0descendants
- K153303EUROIMMUN Anti-West Nile Virus ELISA (IgG)Euroimmun Us, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993724 | HSV-2 Elisa Igg, Model EL0920G | Mrl Diagnostics | 2000 | — |
| +1 | K031952 | West Nile Virus Igm Capture Elisa, Model EL0300M | Focus Technologies, Inc. | 2003 | — |
| +1 | K040854 | West Nile Virus Igm Capture Elisa | Focus Technologies, Inc. | 2004 | — |
| +1 | K031953 | West Nile Virus Elisa Igg, Model EL0300G | Focus Technologies, Inc. | 2003 | 1 |
| +2 | K153308 | EUROIMMUN Anti-West Nile Virus ELISA (IgM) | Euroimmun Us, Inc. | 2016 | — |
| +2 | K153303 | EUROIMMUN Anti-West Nile Virus ELISA (IgG) | Euroimmun Us, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2016 | 2 | 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 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? (3)
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 |
|---|---|---|---|
| * | — | HSV-2 ELISA Test System, Zeus Scientific, Inc. Named without a submission number | |
| * | — | HSV-2 Western Blot, University of Washington Named without a submission number | |
| * | — | HSV-2 Culture, University of Washington Named without a submission number |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K031952 (Focus Technologies, Inc., 2003) has gone furthest, with 3 descendants of its own.
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.
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?
MRL Diagnostics' HSV-2 ELISA IgG test is intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-2 in human sera. In conjunction with the MRL HSV-1 ELISA IgG, the test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. The predictive value of a positive or negative result depends on the population's prevalence and the pretest likelihood of HSV-2 infection. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, for testing of immunocompromised patients, or for use with automated equipment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993724 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993724: HSV-2 Elisa Igg, Model EL0920G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993724
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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