510(k) · Cleared
ClearedPlexus Ebv Igm Multi-Analyte Diagnostics, Model: MP0600M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Focus Diagnostics, Inc. · LJN Antibody Igm, If, Epstein-Barr Virus
Cleared on Aug 4, 2008 after a 245-day review. The FDA summary names its predicate without a number.
- Decided
- Aug 4, 2008
- Review
- 245 days
- Class
- Class I
- Product code
- LJN
- Recalls
- None
- 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 LJN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | — | Osom® Mono Test Named without a submission number | |
| * | — | Diamedix EBV VCA IgM ELISA Named without a submission number | |
| * | — | Athena Multi-Lyte EBV VCA IgM Test System Named without a submission number | |
| * | — | Epstein-Barr Virus VCA (IgM) Recomb Immun Antibod (IFA) 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LJN devicesLJN Antibody Igm, If, Epstein-Barr Virus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LJN
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · LJN
Too few LJN 510(k)s in any year since 2007 to give a median.
Recalls per year · LJN
No recall names LJN since 2007.
Adverse event reports per year · LJN
No MAUDE report names LJN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 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 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Focus Diagnostics' PlexusTM EBV IgM Multi-Analyte Diagnostics test kit is intended for qualitatively detecting the presence or absence of human IgM class antibodies to viral capsid antigen (VCA), and heterophile antibodies in human sera. The test is indicated as an aid in the diagnosis of EBV infection and EBV-associated infectious mononucleosis.
The performance of this assay has not been established for use in the diagnosis of nasopharyngeal carcinoma and Burkitt's lymphoma, for testing of immunocompromised patients, for use by a point of care facility or for use with automated equipment. This assay has not been evaluated for donor screening.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073381 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073381: Plexus Ebv Igm Multi-Analyte Diagnostics, Model: MP0600M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073381
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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