# K973823: PR 3 Antibody Kit

- Pathway: 510(k) (Traditional)
- Applicant: Hemagen Diagnostics, Inc.
- Decided: Nov 13, 1997 after 37 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 K954105 (1996). 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)
- K954105: Eia Kit for the Detction of Anti-PR3 Antibodies, Scimedx Corp. (1996) Summary page 1.

## Indications for use
This enzyme-linked immunosorbent assay (ELISA) is indicated for the detection of autoantibodies to the antigen Proteinase 3 in human serum. The presence of PR-3 antibodies, in combination with clinical observations and other serological tests, can aid in the diagnosis of Wegener's granulomatosis (WG) and other conditions associated with elevated anti-neutrophil cytoplasmic antibodies (ANCA)

Source page: https://510kreport.com/device/K973823
Methodology: https://510kreport.com/methodology