# K974702: Orgentec Anti-PR3 (C-Anca) Elisa

- Pathway: 510(k) (Traditional)
- Applicant: American Laboratory Products Co., Ltd.
- Decided: Feb 17, 1998 after 71 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.
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 anti-PR3 indirect solid phase enzyme immunometric assay (ELISA) is designed for the semi-quantitative measurement of IgG class autoantibodies directed against proteinase 3 (PR3) and to aid in the diagnosis of autoimmune vasculitides such as Wegener's granulomatosis.

Source page: https://510kreport.com/device/K974702
Methodology: https://510kreport.com/methodology