510(k) · Cleared
Recalled · Class II · 2014Ebv-Vca Igg Elisa Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diamedix Corp. · LSE Epstein-Barr Virus, Other
Cleared on Mar 4, 1999 after a 286-day review. The FDA summary names its predicate without a number. It has been recalled once.
- Decided
- Mar 4, 1999
- Review
- 286 days
- Class
- Class I
- Product code
- LSE
- Recalls
- 1
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | Wampole VCA IgG ELISA Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 20, 2014 | Class II | Z-1686-2016 | Unknown/Undetermined by firm | A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance. |
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?
For the qualitative and semi-quantitative determination of IgG antibodies to Epstein-Barr Virus (recombinant) Viral Capsid Antigen (EBV-VCA IgG) in human serum by indirect enzyme immunoassay. The Is-EBV-VCA IgG Test Kit may be used in combination with other Epstein-Barr serologies (Viral Capsid Antigen (VCA) IgM, Epstein-Barr Nuclear Antigen-1 (EBNA-1) IgG and IgM, Early Antigen-Diffuse (EA-D) IgG and IgM and heterophile antibody as an aid in the…
Read the full statement (110 words)
For the qualitative and semi-quantitative determination of IgG antibodies to Epstein-Barr Virus (recombinant) Viral Capsid Antigen (EBV-VCA IgG) in human serum by indirect enzyme immunoassay. The Is-EBV-VCA IgG Test Kit may be used in combination with other Epstein-Barr serologies (Viral Capsid Antigen (VCA) IgM, Epstein-Barr Nuclear Antigen-1 (EBNA-1) IgG and IgM, Early Antigen-Diffuse (EA-D) IgG and IgM and heterophile antibody as an aid in the diagnosis of infectious mononucleosis (IM). The evaluation of paired sera, to determine a significant increase in VCA IgG antibody titer, can also aid in the diagnosis of acute infection. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated Processor.
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/K981812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981812: Ebv-Vca Igg Elisa Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981812
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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