# K013283: Relisa PR3-Anca Test System for Antibodies to Proteinase 3, Model # 7096-16

- Pathway: 510(k) (Traditional)
- Applicant: Immuno Concepts, Inc.
- Decided: Nov 14, 2001 after 43 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
Longest line of descent: 1 generation back to K981029 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981029: Bindazyme Anti-PR3 Enzyme Immunoassay Kit, The Binding Site, Ltd. (1998) Summary page 1.

## Indications for use
This is an enzyme immunoassay test system for the detection of antibodies to Proteinase 3 (PR3) in human serum. This test system is to be used as an aid in the detection of antibodies associated with Wegener‘s granulomatosis and other vasculitides.

Source page: https://510kreport.com/device/K013283
Methodology: https://510kreport.com/methodology