# K072358: Bioplex Vasculitis Kit

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: Oct 31, 2007 after 70 days
- Product code: MVJ (Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm))
- Device class: 2
- Regulation: 21 CFR 866.5660
- 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 K961340 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041040: Varelisa Mpo Anca, Model 17648/17696, Sweden Diagnostics (Germany) GmbH (2004) Summary page 2.
- K041043: Varelisa PR3 Anca, Model Number 17748/17796, Pharmacia Deutschland GmbH (2004) Summary page 2.
- K984336: Quanta Lite GBM Elisa, Inova Diagnostics, Inc. (1999) Summary page 2.
- K961340: Nova Lite Anca, Inova Diagnostics, Inc. (1996) Summary page 2.

## Indications for use
The BioPlexTM 2200 Vasculitis kit is a multiplex flow immunoassay intended for the semi-quantitative detection of IgG autoantibodies to Myeloperoxidase (MPO), serine Proteinase 3 (PR3) and Glomerular Basement Membrane (GBM) in human serum. The BioPlex 2200 Vasculitis kit is intended for use with the Bio-Rad BioPlex 2200 System. Uses: The test system is used to detect the presence of antibodies in serum samples, as an aid in the diagnosis of certain autoimmune vasculitides such as Microscopic Polyangiitis (MPA), Necrotising Glomerulonephritis, Churg-Strauss Syndrome, Wegener's Granulomatosis and autoimmune renal disorders, such as Goodpasture's syndrome, in conjunction with clinical findings and other laboratory tests. The BioPlex 2200 Vasculitis Calibrator Set is intended for the calibration of the BioPlex 2200 Vasculitis Reagent Pack. The BioPlex 2200 Vasculitis Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 Vasculitis Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 Vasculitis Control Set has not been established with any other Vasculitis assays.

Source page: https://510kreport.com/device/K072358
Methodology: https://510kreport.com/methodology