# K973822: Virgo Anca Screen 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.
- K954062: Eia Kit for the Detection of Anti-Mpo 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 antigens Proteinase 3 (PR-3) and myeloperoxidase (MPO) in human serum. The presence of these antibodies, in combination with clinical observations and other serological tests, can aid in the diagnosis of Wegener's granulomatosis (WG), polyarteritis, necrotizing glomerulonephritis and other conditions associated with elevated anti-neutrophil cytoplasmic antibodies (ANCA). Since a positive test result with this assay does not indicate which ANCA is (are) present, all positives should be confirmed using assays designed for particular ANCA specificities.

Source page: https://510kreport.com/device/K973822
Methodology: https://510kreport.com/methodology