# K123021: Bioplex 2200 Ebv Igm Kit

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: Nov 2, 2012 after 36 days
- Product code: LJN (Antibody Igm, If, Epstein-Barr Virus)
- Device class: 1
- Regulation: 21 CFR 866.3235
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K862008 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062213: Bioplex 2200 Ebv Igm Panel on Bioplex 2200 Multi-Analyte Detection System, Bio-Rad Laboratories, Inc. (2006) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K123021
Methodology: https://510kreport.com/methodology