# K013285: Relisa Mpo-Anca Test System for Antibodies to Myeloperoxidase, Model # 7096-15

- Pathway: 510(k) (Traditional)
- Applicant: Immuno Concepts, Inc.
- Decided: Nov 14, 2001 after 43 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
This is an enzyme immunoassay test system for the detection of antibodies to myeloperoxidase (MPO) in human serum. This test system is to be used as an aid in the detection of antibodies associated with microscopic polyangiitis, idiopathic necrotizing and crescentic glomerulonephritis, and other vasculitides.

Source page: https://510kreport.com/device/K013285
Methodology: https://510kreport.com/methodology