# K971689: Immunoscan Anti-Myeloperoxidase Antibodies (Mpo-Anca) Quantitative Kit

- Pathway: 510(k) (Traditional)
- Applicant: Euro-Diagnostica AB
- Decided: Oct 29, 1997 after 175 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Euro-Diagnostica Immunoscan MPO-ANCA Kit is an enzyme immunoassay (EIA) kit for the in vitro detection in human serum of the subclass of Anti-Neutrophil Cytoplasmic Antibodies (ANCA) directed against myeloperoxidase to be used as an aid in the diagnosis of crescentic glomerulonephritis.

Source page: https://510kreport.com/device/K971689
Methodology: https://510kreport.com/methodology