# K974166: Wielisa Mpo Anca Test System

- Pathway: 510(k) (Traditional)
- Applicant: Wieslab AB
- Decided: Feb 17, 1998 after 104 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. The FDA summary names its predicate without a number.
- (no number) Immunoscan MPO ANCA ELISA Kit: named in the summary without a submission number

## Indications for use
Wielisa MPO ANCA Test Kit. An Enzyme Linked Immunosorbent Assay (ELISA) for the detection and semi-quantitation of IgG antibodies in human serum to MPO (Myeloperoxidase). The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Microscopic polyangiitis..

Source page: https://510kreport.com/device/K974166
Methodology: https://510kreport.com/methodology