# K984619: Binding Site Bindazyme Anti-GBM Eia Diagnostic Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site, Ltd.
- Decided: Feb 23, 1999 after 56 days
- Product code: MVJ (Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm))
- 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
For the in-vitro measurement of specific IgG autoantibodies against the glomerular basement membrane (GBM) specifically the C-terminal end of type IV collagen, present in human serum. It is intended as an aid in the diagnosis of Goodpasture's syndrome, in conjunction with other clinical findings.

Source page: https://510kreport.com/device/K984619
Methodology: https://510kreport.com/methodology