510(k) · Cleared
ClearedZeus Elisa HSV GG-2 Igg Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeus Scientific, Inc. · MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Cleared on May 20, 2011 after a 163-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 20, 2011
- Review
- 163 days
- Class
- Class II
- Product code
- MYF
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 MYF devicesMYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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?
The ZEUS ELISA HSV gG-2 lgG Test System is intended for the qualitative detection of
type specific lgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human
serum. The test is intended for testing sexually active individuals or pregnant women for
aiding in the presumptive diagnosis of HSV-2 infection.
The predictive value of positive or negative results depends on the population's
prevalence and the pretest likelihood of 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, or immunocompromised patients.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K103603 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103603: Zeus Elisa HSV GG-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/K103603
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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