510(k) · Cleared
ClearedEbna Igg Eia Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunoprobe, Inc. · LLM Test, Antigen, Nuclear, Epstein-Barr Virus
Cleared on Apr 29, 1996 after a 391-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Apr 29, 1996
- Review
- 391 days
- Class
- Class I
- Product code
- LLM
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK951549 Ebna Igg Eia Test SystemImmunoprobe, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK062211 Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection…Bio-Rad Laboratories, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK120439 Bioplex 2200 Ebv Igg and Syphilis IggBio-Rad Laboratories, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951549 | Ebna Igg Eia Test System | Immunoprobe, Inc. | 1996 | — |
| +1 | K062211 | Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection System | Bio-Rad Laboratories, Inc. | 2006 | 2 |
| +2 | K120439 | Bioplex 2200 Ebv Igg and Syphilis Igg | Bio-Rad Laboratories, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
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 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? (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 |
|---|---|---|---|
| * | — | BioWhitttaker’s EBNA STAT test Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062211 | Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection System | 2006 | 1 |
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?
- Of its descendants, K062211 (Bio-Rad Laboratories, Inc., 2006) has gone furthest, with 1 descendant of its own.
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?
The ImmunoProbe anti-EBNA-1 IgG assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EA (R&D), and heterophile) as an aid in the diagnosis of infectious mononucleosts.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K951549 · printed Nov 5, 2026
Cite this page
510(k) Report. “K951549: Ebna Igg Eia Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951549
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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