510(k) · Cleared
ClearedAthena Multi-Lyte HSV 1 & 2 Igg Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeus Scientific, Inc. · MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Cleared on May 30, 2008 as substantially equivalent to K000238 (Mrl Diagnostics, 2000) after a 298-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- May 30, 2008
- Review
- 298 days
- Class
- Class II
- Product code
- MXJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000238 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK000238 HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900GMrl Diagnostics · 2000 · Recalled
- This deviceK072178 Athena Multi-Lyte HSV 1 & 2 Igg Test SystemZeus Scientific, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000238 | HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900G | Mrl Diagnostics | 2000 | 1 |
| 0 (this device) | K072178 | Athena Multi-Lyte HSV 1 & 2 Igg Test System | Zeus Scientific, Inc. | 2008 | — |
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? (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 |
|---|---|---|---|
| * | K000238 | HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900GSummary page 1…Predicate Device Information Manufacturer: Focus Technologies Name: HerpeSelect 1 and 2 Immunoblot IgG Test System Methodology: Immunoblot 510(k) Number: K000238 4 Device Description The AtheNA Multi-Lyte HSV 1 & 2 IgG Test System is a microparticle immunoassay system intended… | 2000 |
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.
What does this lineage say?
- Its one ancestor has a recall.
- 13 other devices also cite its predicate K000238.
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. 2008, 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?
The Zeus Scientific, Inc. AtheNA Multi-Lyte® HSV 1 & 2 IgG Test System is intended for the qualitative detection of the presence or absence of human IgG class antibodies to Herpes Simplex virus I and 2 in human sera. The test is indicated for sexually active adults and expectant mothers, as an aid for presumptively diagnosing Herpes Simplex 1 and 2. The predictive value of positive or negative results depends on the population's prevalence and the…
Read the full statement (125 words)
The Zeus Scientific, Inc. AtheNA Multi-Lyte® HSV 1 & 2 IgG Test System is intended for the qualitative detection of the presence or absence of human IgG class antibodies to Herpes Simplex virus I and 2 in human sera. The test is indicated for sexually active adults and expectant mothers, as an aid for presumptively diagnosing Herpes Simplex 1 and 2. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-1 and HSV-2. The test is not intended for donor screening or for self testing.
The performance of this assay has not been established for use in a pediatric population, neonates, immunocompromised patients, for use by point of care facilities or for use with automated equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072178: Athena Multi-Lyte HSV 1 & 2 Igg Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072178
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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