510(k) · Cleared
ClearedAthena Multi-Lyte Ebv Igg Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeus Scientific, Inc. · JRY Antiserum, Fluorescent, Epstein-Barr Virus
Cleared on Apr 29, 2005 after a 266-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 29, 2005
- Review
- 266 days
- Class
- Class I
- Product code
- JRY
- 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 JRY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 JRY devicesJRY Antiserum, Fluorescent, Epstein-Barr Virus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JRY
FDA has decided no JRY device since 2007.
Median 510(k) review, days · JRY
Too few JRY 510(k)s in any year since 2007 to give a median.
Recalls per year · JRY
No recall names JRY since 2007.
Adverse event reports per year · JRY
No MAUDE report names JRY since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Zeus Scientific, Inc. AtheNA Multi-Lyte EBV IgG Test System is intended for the qualitative detection of lgG class antibody to three separate EBV Antigens (EBV-VCA gg-1 125, EBV-EA 'total' and recombinant EBNA-1) in human serum using the AtheNA Multi-Lyte System. The test system is intended to be used with these EBV IgG markers along with anti-EBV VCA IgM to aid in the laboratory diagnosis of EBV-associated infectious mononucleosis and to provide epidemiological information on the diseases caused by EBV virus.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042118 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042118: Athena Multi-Lyte Ebv Igg Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042118
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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