# K981030: Bindazyme Anti-Mpo Enzyme Immunoassay Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site, Ltd.
- Decided: Jul 20, 1998 after 123 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K040586: Mesacup Test Mpo, Model 11053 (2004), 0 descendants of its own
- K013285: Relisa Mpo-Anca Test System for Antibodies to Myeloperoxidase, Model # 7096-15 (2001), 0 descendants of its own

## Indications for use
This assay is intended for the in-vitro measurement of specific IgG autoantibodies against myeloperoxidase (MPO) present in serum, as an aid in the diagnosis of certain types of autoimmune vasculitis, including crescentric glomerulonephritis and microscopic polyarteritis, in conjunction with other clinical findings.

Source page: https://510kreport.com/device/K981030
Methodology: https://510kreport.com/methodology