# K062213: Bioplex 2200 Ebv Igm Panel on 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K862008 (1986). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946157: Incstar Epstein-Barr Viral Capsid Antigen (Vca) LGM Elisa Kit, Incstar Corp. (1995) Summary page 2.
- K862008: Mono-Latex (TM) Slide Test, Armkel, LLC (1986) Summary page 2.

## Most influential descendants
- K123021: Bioplex 2200 Ebv Igm Kit (2012), 0 descendants of its own

## Recalls of this device
- Nov 13, 2007 · Not classified · Z-1158-2008: False negative results due to reagent packs exhibiting low signal.

## Indications for use
The BioPlex 2200 EBV IgM 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 BioPlex 2200 EBV IgG kit as an aid in the laboratory diagnosis of infectious mononucleosis (IM). The EBV IgM 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 IgM Calibrator Set is intended for the calibration of the BioPlex 2200 EBV IgM Reagent Pack. The BioPlex 2200 EBV IgM 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 IgM Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 EBV IgM Control Set has not been established with any other EBV assays.

Source page: https://510kreport.com/device/K062213
Methodology: https://510kreport.com/methodology