510(k) · Cleared
ClearedHerpeselect 1 Elisa Igg, Model EL0910G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Focus Technologies, Inc. · MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Cleared on Jul 29, 2002 after an 87-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Jul 29, 2002
- Review
- 87 days
- Class
- Class II
- Product code
- MXJ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK021429 Herpeselect 1 Elisa Igg, Model EL0910GFocus Technologies, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK090409 Bioplex 2200 HSV-1 and HSV-2 Igg on the Bioplex 2200 Multi-Analyte…Bio-Rad Laboratories · 2009
- Descendant · 2 generations on · 0 of its ownK120959 Bioplex 2200 HSV-1 and HSV-2 Igg KitBio-Rad Laboratories · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021429 | Herpeselect 1 Elisa Igg, Model EL0910G | Focus Technologies, Inc. | 2002 | — |
| +1 | K090409 | Bioplex 2200 HSV-1 and HSV-2 Igg on the Bioplex 2200 Multi-Analyte Detection… | Bio-Rad Laboratories | 2009 | — |
| +2 | K120959 | Bioplex 2200 HSV-1 and HSV-2 Igg Kit | Bio-Rad Laboratories | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 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 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 6.1 · 1 generation · no Class I recall
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | — | HerpeSelect®1 ELISA IgG (manual option) Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090409 | Bioplex 2200 HSV-1 and HSV-2 Igg on the Bioplex 2200 Multi-Analyte Detection System | 2009 | 1 |
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, K090409 (Bio-Rad Laboratories, 2009) has gone furthest, with 1 descendant of its own.
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?
Focus Technologies' Herpeselect® 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 Focus Herpeselect® 2 ELISA IgG, the test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. The assay can be used manually or in conjunction with an automated system as outlined in the…
Read the full statement (113 words)
Focus Technologies' Herpeselect® 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 Focus Herpeselect® 2 ELISA IgG, the test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. The assay can be used manually or in conjunction with an automated system as outlined in the package insert. The user is responsible for assay performance characteristics when an automated system is used. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, or for testing of immunocompromised patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021429 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021429: Herpeselect 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/K021429
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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