# K973824: Virgo Panco 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 K954062 (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)
- 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 antigen Myeloperoxddase (MPO) in human serum. The presence of MPO antibodies, in combination with clinical observations and other serological tests, can aid in the diagnosis of polyarteritis, glomerulonephritis and other conditions associated with elevated anfl-neuhnfinmcgflc antibodies (ANCA).

Source page: https://510kreport.com/device/K973824
Methodology: https://510kreport.com/methodology