# K120439: Bioplex 2200 Ebv Igg and Syphilis Igg

- Pathway: 510(k) (Special)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Mar 14, 2012 after 30 days
- Product code: LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum)
- Device class: 2
- Regulation: 21 CFR 866.3830
- 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 K951549 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062211: Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection System, Bio-Rad Laboratories, Inc. (2006)
- K063866: Bioplex 2200 Syphilis Igg Kit on the Bioplex 2200 Multi-Analyte Detection System, Bio-Rad Laboratories (2007) Summary page 4.

## Indications for use
The BioPlex® 2200 EBV IgG kit is a multiplex flow immunoassay intended for the qualitative detection of JgG antibodies to three (3) separate EBV antigens; Epstein-Barr Virus Nuclear Antigen- I (EBV NA-i1), 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 1gM kit as an aid in the laboratory diagnosis of infectious mononucleosis (TM). The EBV JgG 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 Syphilis IgG kit is a multiplex flow immunoassay intended for the qualitative detection Treponema pallidum in human serum. The test system, when used in conjunction with non-treponemal based assays, provides serological evidence of infection with T pallidum. This test system also confirms reactive test results form non-treponemal based screening assays. The Syphilis IgO kit is intended for use with the Bio-Rad BioPlex 2200 System. The BioPlex 2200 Syphilis IgG kit is not intended for use in screening blood or plasma donors Warning: A positive result is not useful for establishing a diagnosis of Syphilis. In most situations, such a result may reflect prior treated infection; a negative result can exclude a diagnosis of syphilis except for incubating or early primary disease.

Source page: https://510kreport.com/device/K120439
Methodology: https://510kreport.com/methodology