510(k) · Cleared
ClearedHerpeselect Express Igg, Herpeselect Express Controls, Models RT0920G, RT0950
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Focus Diagnostics, Inc. · MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Cleared on Sep 24, 2007 after a 112-day review. The FDA summary names its predicate without a number.
- Decided
- Sep 24, 2007
- Review
- 112 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? (2)
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 |
|---|---|---|---|
| * | — | HerpeSelect 1 and 2 Immunoblot IgG Named without a submission number | |
| * | — | HerpeSelect-2 ELISA IgG 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. 2007, this device’s year, is highlighted.
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?
HerpeSelect® Express is a rapid test intended for qualitatively detecting the presence or absence of human IgG class antibodies to herpes simplex virus type 2 (HSV-2) in human whole blood (venous or capillary) or serum. The test is indicated for testing sexually active adults or pregnant women to aid in the presumptive diagnosis of HSV-2 infection.
The HerpeSelect® Express IgG device has not been established for use in the pediatrics population, for neonatal screening, or for testing immunocompromised patients. This kit is not intended for self-testing, and this test is neither FDA cleared nor approved for testing blood or plasma donors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071510 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071510: Herpeselect Express Igg, Herpeselect Express Controls, Models RT0920G, RT0950.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071510
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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