# K981029: Bindazyme Anti-PR3 Enzyme Immunoassay Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site, Ltd.
- Decided: Jul 20, 1998 after 123 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.
2 later devices descend from it; 2 cite 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K040711: Mesacup Test PR-3 (2004), 0 descendants of its own
- K013283: Relisa PR3-Anca Test System for Antibodies to Proteinase 3, Model # 7096-16 (2001), 0 descendants of its own

## Indications for use
This assay is designed for the in-vitro measurement of specific IgG autoantibodies against proteinase 3 (PR3) present in human serum, as an aid in the diagnosis of Wegener's granulomatosis and certain forms of autoimmune vasculitis in conjunction with other clinical findings.

Source page: https://510kreport.com/device/K981029
Methodology: https://510kreport.com/methodology