510(k) · Cleared
ClearedBioplex 2200 Ebv Igm Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories · LJN Antibody Igm, If, Epstein-Barr Virus
Cleared on Nov 2, 2012 as substantially equivalent to K062213 (Bio-Rad Laboratories, Inc., 2006) after a 36-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Nov 2, 2012
- Review
- 36 days
- Class
- Class I
- Product code
- LJN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K862008 (1986). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K862008 | Mono-Latex (TM) Slide Test | Armkel, LLC | 1986 | — |
| −1 | K062213 | Bioplex 2200 Ebv Igm Panel on Bioplex 2200 Multi-Analyte Detection System | Bio-Rad Laboratories, Inc. | 2006 | 1 |
| 0 (this device) | K123021 | Bioplex 2200 Ebv Igm Kit | Bio-Rad Laboratories | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 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? (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 |
|---|---|---|---|
| * | K062213 | Bioplex 2200 Ebv Igm Panel on Bioplex 2200 Multi-Analyte Detection SystemSummary page 1…r 30, 2012 Applicant: Bio-Rad Laboratories Contact: Juang Wang Regulatory Affairs Representative Purpose for Submission: Modification to cleared device (K0622 13), see section Substantial Equivalence Information for a description of the changes. Measurand: Epstein-Baar Virus Viral C… | 2006 |
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?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 20.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
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. 2012, 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?
The Biolex® 2200 EBV 1gM kit is a multiplex flow immunoassay intended for the qualitative detection of two (2) separate analytes; Epstein-Barr Virus Viral Capsid Antigen (EBV VCA) IgM antibodies and Heterophile antibodies in human serum. The test system can be used in conjunction with the Biolex 2200 EBV IgG kit as an aid in the laboratory diagnosis of infectious mononucleosis (IM). The Biolex® 2200 EBV 1gM kit is intended for use with the Bio-Rad…
Read the full statement (193 words)
The Biolex® 2200 EBV 1gM kit is a multiplex flow immunoassay intended for the qualitative detection of two (2) separate analytes; Epstein-Barr Virus Viral Capsid Antigen (EBV VCA) IgM antibodies and Heterophile antibodies in human serum. The test system can be used in conjunction with the Biolex 2200 EBV IgG kit as an aid in the laboratory diagnosis of infectious mononucleosis (IM).
The Biolex® 2200 EBV 1gM kit is intended for use with the Bio-Rad Biolex® 2200 System.
Assay performance characteristics have not been established for inmmnocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. Assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, Burkitt's lymphoma, and other EBV-associated lymphomas.
The Biolex® 2200 EWBV lgM Calibrator Set is intended for the calibration of the Biolex® 2200 EBV 1gM Reagent Pack.
The Biolex® 2200 EBV 1gM Control Set is intended for use as an assayed quality control to monitor the overall performance of the Biolex® 2200 Instrument and Biolex® 2200 EBV 1gM Reagent Pack in the clinical laboratory. The performance of the Biolex® 2200 EBV 1gM Control Set has not been established with any other EBV 1gM antibody assays.
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/K123021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123021: Bioplex 2200 Ebv Igm Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123021
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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