# K981750: Wielisa Anti-GBM, Anca Screening Kit Test System

- Pathway: 510(k) (Traditional)
- Applicant: Wieslab AB
- Decided: Jul 22, 1998 after 65 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) Wielisa PR-3 ANCA ELISA Kit: named in the summary without a submission number
- (no number) Wielisa MPO ANCA ELISA Kit: named in the summary without a submission number
- (no number) Wielisa anti-GBM ELISA Kit: named in the summary without a submission number

## Indications for use
The Wielisa Anti-GBM, ANCA Screening Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of antibodies to glomerular basement membrane (GBM), Proteinase-3 (PR-3) and Myeloperoxidase (MPO) in human sera. 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 reno-pulmonary syndromes and rapidly progressive glomerulonephritis, especially Goodpasture syndrome (GP), Wegener’s granulomatosis (WG) and microcopic polyangiitis (MP). The assay is intended for use in patients with signs and symptoms consistent with GP, WG, and MP. It is not intended for screening a healthy population. A positive result should always be confirmed by a semi-quantitative assay.

Source page: https://510kreport.com/device/K981750
Methodology: https://510kreport.com/methodology