510(k) · Cleared
ClearedHSV-1 Elisa Igg, Model EL0910G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mrl Diagnostics · MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Cleared on Feb 9, 2000 after a 96-day review. The FDA summary names its predicate without a number.
- Decided
- Feb 9, 2000
- Review
- 96 days
- Class
- Class II
- Product code
- MXJ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 MXJ? 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 MXJ device
- #1 K213987 ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG…score 6.0 · 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-1 ELISA Test System, Zeus Scientific, Inc. Named without a submission number | |
| * | — | HSV-1 Western Blot, University of Washington Named without a submission number | |
| * | — | HSV-1 Culture, University of Washington Named without a submission number |
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 MXJ devicesMXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MXJ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MXJ
123in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MXJ
No recall names MXJ since 2007.
Adverse event reports per year · MXJ
1in 2025
MAUDE reports naming product code MXJ, 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 | 3 | 123 | 0 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 140 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
MRL Diagnostics' HSV-1 ELISA IgG test is intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 in human sera. In conjunction with the MRL HSV-2 ELISA IgG, the test is indicated for 1) testing sexually active adults, with or without a clinical history of herpes, for aiding in the presumptive diagnosis of HSV infection to identify persons who are at risk for transmitting or acquiring HSV so they may be counseled, and 2) testing expectant mothers for aiding in the presumptive assessment of the risk for acquiring and/or transmitting HSV to their child, so they may be counseled.
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/K993754 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993754: HSV-1 Elisa Igg, Model EL0910G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993754
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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