510(k) · Cleared
ClearedBiotest Anti-Ebv Recombinant, Ebna Igg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotest Diagnostics Corp. · LSE Epstein-Barr Virus, Other
Cleared on Jun 9, 1999 as substantially equivalent to K946158 (Incstar Corp., 1995) after a 222-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jun 9, 1999
- Review
- 222 days
- Class
- Class I
- Product code
- LSE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K946158 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK946158 Incstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa KitIncstar Corp. · 1995 · Recalled
- This deviceK983841 Biotest Anti-Ebv Recombinant, Ebna IggBiotest Diagnostics Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946158 | Incstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa Kit | Incstar Corp. | 1995 | 1 |
| 0 (this device) | K983841 | Biotest Anti-Ebv Recombinant, Ebna Igg | Biotest Diagnostics Corp. | 1999 | — |
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 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? (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 |
|---|---|---|---|
| * | K946158 | Incstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa KitSummary page 2…Classification Name: Epstein-Barr virus serological reagents C. Legally Marketed Device Biotest Diagnostics claims substantial equivalence to the EBNA IgG ELISA Kit (K946158) currently in commercial distribution by INCSTAR Corporation, Stillwater, MN. D. Device Description Using recombinant DNA techn… | 1995 |
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.
What does this lineage say?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K946158.
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?
The Biotest EBNA IgG ELISA is an enzyme immunoassay for the detection of IgG antibodies to the Epstein-Barr (EBV) EBNA-1 (Nuclear Antigen-1) in human serum or plasma.
It is indicated for use, in conjunction with other clinical and patient data obtained in assays for other Epstein-Barr antigens such as Early Antigen IgG and IgM, in the serological diagnosis of EBV infection.
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/K983841 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983841: Biotest Anti-Ebv Recombinant, Ebna Igg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983841
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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