# K092587: Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection System

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: Dec 3, 2010 after 466 days
- Product code: LFX (Enzyme Linked Immunoabsorbent Assay, Rubella)
- Device class: 2
- Regulation: 21 CFR 866.3510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K933549 (1994). 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)
- K010668: Bayer Diagnostics Advia Centaur Rubella Igm Assay, Bayer Corp. (2001) Summary page 5.
- K933549: Vidas CMV Igm Assay, Biomerieux Vitek, Inc. (1994) Summary page 1.

## Most influential descendants
- K170509: BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set (2017), 0 descendants of its own

## Indications for use
The BioPlex@- 2200 Rubella and CMV IgM kit is a multiplex flow inmmoassay intended for the qualitative detection of 1gM antibodies to Rubella and Cytomnegalovirus (CMV) in human serum and potassium EDTA or sodium heparin plasma. The BioPlex 2200 Rubella and CMIV 1gM kit is intended for use with the Bio-Rad BioPlex 2200 System. This kit is intended as an aid in the diagnosis of a curr ent or recent Rubella and/or CMV infection, in individuals suspected of having one of the respective disease states including women of child bearing age. This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors. Performance characteristics for the Rubella and CMV 1gM assays have not been evaluated in immunosupressed or organ transplant individuals. Performance characteristics of this kit have not been established for use in neonatal screening or for use at point of care facilities. The BioPlex® 2200 Rubella and CMV 1gM Calibrator Set is intended for the calibration of the Biollex - 2200 Rubella and CMV 1gM Reagent Pack. The Biollex® 2200 Rubella and CMV 1gM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 instrument and BioPlex 2200 Rubella and CMV 1gM Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 Rubella and CMV 1gM Control Set has not been established with any other Rubella and CMV 1gM assays.

Source page: https://510kreport.com/device/K092587
Methodology: https://510kreport.com/methodology