# K062211: Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection System

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Dec 8, 2006 after 129 days
- Product code: LSE (Epstein-Barr Virus, Other)
- Device class: 1
- Regulation: 21 CFR 866.3235
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951549 (1996). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951549: Ebna Igg Eia Test System, Immunoprobe, Inc. (1996) Summary page 2.
- K980912: Vca Igg Elisa Test System, Clark Laboratories, Inc. (1998) Summary page 2.
- K973123: EA-D Igg Elisa Test System, Clark Laboratories, Inc. (1998) Summary page 2.

## Most influential descendants
- K120439: Bioplex 2200 Ebv Igg and Syphilis Igg (2012), 0 descendants of its own

## Recalls of this device
- Mar 11, 2011 · Not classified · Z-2082-2011: 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: False negative results due to reagent packs exhibiting low signal.

## Indications for use
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.

Source page: https://510kreport.com/device/K062211
Methodology: https://510kreport.com/methodology