# K040586: Mesacup Test Mpo, Model 11053

- Pathway: 510(k) (Traditional)
- Applicant: Rhigene, Inc.
- Decided: Mar 22, 2004 after 17 days
- Product code: MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca))
- 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 K981030 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981030: Bindazyme Anti-Mpo Enzyme Immunoassay Kit, The Binding Site, Ltd. (1998) Summary page 1.

## Indications for use
The MESACUP TEST MPO is a semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG anti-myeloperoxidasc (MPO) antibodies in human serum. The MESACUP TEST MPO is intended for in vitro diagnostic use as an aid in the diagnosis of certain systemic vasculitides such as microscopic polyarteritis and crescentic glomerulonephritis. The MESACUPTest MPO is intended to be used by clinical (hospital and reference) laboratories.

Source page: https://510kreport.com/device/K040586
Methodology: https://510kreport.com/methodology