# K971464: Immunoscan Anti-GBM Quantitative Kit

- Pathway: 510(k) (Traditional)
- Applicant: Euro-Diagnostica AB
- Decided: Oct 29, 1997 after 190 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.
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 Anti-GBM Kit is an enzyme immunoassay (EIA) kit for the in vitro diagnostic detection of anti-Glomerular Basement Membrane (GBM) antibodies in human serum. This kit is useful as an aid in the diagnosis of autoimmune renal disorders such as Goodpasture’s syndrome.

Source page: https://510kreport.com/device/K971464
Methodology: https://510kreport.com/methodology