510(k) · Cleared
ClearedZeus Scientific Inc., Anti-Ebv EA Igg Elisa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeus Scientific, Inc. · LSE Epstein-Barr Virus, Other
Cleared on Aug 21, 1998 after a 147-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 21, 1998
- Review
- 147 days
- Class
- Class I
- Product code
- LSE
- 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 LSE? 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 LSE device
- #1 K233606 ADVIA Centaur EBV-VCA IgMscore 8.1 · 2 generations · no Class I recall
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 LSE devicesLSE Epstein-Barr Virus, Other: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LSE
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LSE
Too few LSE 510(k)s in any year since 2007 to give a median.
Recalls per year · LSE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LSE
1in 2014
MAUDE reports naming product code LSE, 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 | 0 | — | 2 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 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 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Epstein-Barr Virus (EBV) causes infectious mononucleosis; a self-limiting lymphoproliferative disease. EBV is a ubiquitous human virus. By adulthood, virtually everyone has been infected and has developed immunity to the virus. [n underdeveloped countries, seroconversion to the virus takes place in early childhood and is usually asymptomatic. Following seroconversion, whether symptomatic or not, EBV establishes a chronic latent infection in B lymphocytes…
Read the full statement (199 words)
Epstein-Barr Virus (EBV) causes infectious mononucleosis; a self-limiting lymphoproliferative disease. EBV is a ubiquitous human virus. By adulthood, virtually everyone has been infected and has developed immunity to the virus. [n underdeveloped countries, seroconversion to the virus takes place in early childhood and is usually asymptomatic.
Following seroconversion, whether symptomatic or not, EBV establishes a chronic latent infection in B lymphocytes which lasts probably for life. Reactivation of the latent viral carrier state, as evidenced by increased rates of virus shedding, is enhanced by immunosuppression, pregnancy, malnutrition or disease.
Antibody titers to specific EBV antigens correlate with different stages of infectious mononucleosis. Antibodies to EA may appear transiently for up to three months or longer during the acute phase of IM in 85% of patients. Antibodies to EA together with antibodies to EBNA and high titers of IgG to VCA may be associated with reactivation of the latent viral carrier state.
This test system is designed to detect IgG antibodies to EBV EA in human serum specimens. This test system is intended to be used as an aid in the diagnosis of infectious mononucleosis. The performance characteristics have not been established to aid in the diagnosis of acute IM.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981120: Zeus Scientific Inc., Anti-Ebv EA Igg Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981120
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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