510(k) · Cleared
ClearedThe Aptus (Automated) Application of the Ebna Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for TH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeus Scientific, Inc. · LLM Test, Antigen, Nuclear, Epstein-Barr Virus
Cleared on Jan 11, 1999 after a 54-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 11, 1999
- Review
- 54 days
- Class
- Class I
- Product code
- LLM
- 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 LLM? 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 LLM device
- #1 K233605 ADVIA Centaur EBV-EBNA IgGscore 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 LLM devicesLLM Test, Antigen, Nuclear, Epstein-Barr Virus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LLM
Too few LLM 510(k)s in any year since 2007 to give a median.
Recalls per year · LLM
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLM
No MAUDE report names LLM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 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 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This test system is designed for the manual or automated, qualitative detection of IgG antibodies to EBNA in human serum specimens. When used with other EBV serologies such as Heterophile, VCA IgG an VCA IgM, this test system may aid in the diagnosis and provide information on infectious mononucleosis that may be of value in patient management and treatment. The test is for in vitro diagnostic use.
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/K984133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984133: The Aptus (Automated) Application of the Ebna Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for TH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984133
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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