# K974169: Wielisa Anti-GBM Test System

- Pathway: 510(k) (Traditional)
- Applicant: Wieslab AB
- Decided: Feb 17, 1998 after 104 days
- Product code: DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control)
- 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; 1 cites 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. The FDA summary names its predicate without a number.
- (no number) Immunoscan Anti-GBM ELISA Kit: named in the summary without a submission number

## Most influential descendants
- K140225: Elia PR3S Immunoassay, Elia Mpos Immunoassay, Elia GBM Immunoassay, Elia Anca/GBM Positive Control 100, Elia Anca/GBM PO (2014), 1 descendant of its own
- K173792: EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay (2018), 0 descendants of its own

## Indications for use
The Wielisa anti-GBM Test Kit is an Enzyme Linked Immunosorbent Assay (ELISA) for the detection and semi-quantitation of IgG antibodies in human serum to GBM (glomerular basement membrane). 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 Goodpasture syndrome.

Source page: https://510kreport.com/device/K974169
Methodology: https://510kreport.com/methodology