510(k) · Cleared
Recalled · 2011Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · LSE Epstein-Barr Virus, Other
Cleared on Dec 8, 2006 as substantially equivalent to K951549 (Immunoprobe, Inc., 1996) and 2 other predicates after a 129-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Dec 8, 2006
- Review
- 129 days
- Class
- Class I
- Product code
- LSE
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 1 generation to K951549 (1996). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK951549 Ebna Igg Eia Test SystemImmunoprobe, Inc. · 1996
- This deviceK062211 Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection…Bio-Rad Laboratories, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK120439 Bioplex 2200 Ebv Igg and Syphilis IggBio-Rad Laboratories, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K120439Bioplex 2200 Ebv Igg and Syphilis IggBio-Rad Laboratories, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951549 | Ebna Igg Eia Test System | Immunoprobe, Inc. | 1996 | — |
| 0 (this device) | K062211 | Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection System | Bio-Rad Laboratories, Inc. | 2006 | — |
| +1 | K120439 | Bioplex 2200 Ebv Igg and Syphilis Igg | Bio-Rad Laboratories, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (3)
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 |
|---|---|---|---|
| * | K951549 | Ebna Igg Eia Test SystemSummary page 2…Number Date 1 EBV NA-1 Captia EBV (EBNA-1) ELISA IG 951549 4/29/96 2. EBV VCA Captia EBV VCA P-18 I G… | 1996 |
| * | K980912 | Vca Igg Elisa Test SystemSummary page 2…IG 951549 4/29/96 2. EBV VCA Captia EBV VCA P-18 I G ELISA 980912 3/26/98 3. EBV EA-D Captia EBV EAD IgG ELISA 973123 7/22/98 DEVICE DESCRIPTION… | 1998 |
| * | K973123 | EA-D Igg Elisa Test SystemSummary page 2…G ELISA 980912 3/26/98 3. EBV EA-D Captia EBV EAD IgG ELISA 973123 7/22/98 DEVICE DESCRIPTION The EBV IgG kit uses multiplex flow immunoassay, a methodology that greatly resembles tradit… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120439 | Bioplex 2200 Ebv Igg and Syphilis Igg | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 11, 2011 | Not classified | Z-2082-2011 | Other | Bio-Rad Laboratories confirmed a downward shift in control values for EBV NA-1 analyte when using the BioPlex 2200 EBV IgG Calibrator Set Lot #46704. |
| Nov 13, 2007 | Not classified | Z-1157-2008 | Nonconforming Material/Component | False negative results due to reagent packs exhibiting low signal. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
- Of its descendants, K120439 (Bio-Rad Laboratories, Inc., 2012) has gone furthest, with 0 descendants of its own.
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 BioPlex TM 2200 EBV IgG kit is a multiplex flow immunoassay intended for the qualitative detection of IgG antibodies to three (3) separate EBV antigens; Epstein-Barr Virus Nuclear Antigen-1 (EBV NA-1), Viral Capsid Antigen (EBV VCA), and Early Antigen diffuse (EBV EA-D) in human serum. The test system can be used in conjunction with the BioPlex 2200 EBV IgM kit as an aid in the laboratory diagnosis of infectious mononucleosis (IM). The EBV IgG kit is…
Read the full statement (199 words)
The BioPlex TM 2200 EBV IgG kit is a multiplex flow immunoassay intended for the qualitative detection of IgG antibodies to three (3) separate EBV antigens; Epstein-Barr Virus Nuclear Antigen-1 (EBV NA-1), Viral Capsid Antigen (EBV VCA), and Early Antigen diffuse (EBV EA-D) in human serum. The test system can be used in conjunction with the BioPlex 2200 EBV IgM kit as an aid in the laboratory diagnosis of infectious mononucleosis (IM).
The EBV IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
Assay performance characteristics have not been established for immunocompromised 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 BioPlex 2200 EBV IgG Calibrator Set is intended for the calibration of the BioPlex 2200 EBV IgG Reagent Pack.
The BioPlex 2200 EBV IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 EBV IgG Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 EBV IgG Control Set has not been established with any other EBV 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/K062211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062211: Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062211
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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