# K050715: Quanta Plex Anca Profile

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: May 12, 2005 after 55 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 QUANTA PlexTM ANCA Profile is a fluorescent immunoassay for the semi-quantitative detection of anti-MPO and anti-PR3 autoantibodies in human serum. The presence of these antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of the autoimmune vasculitides microscopic polyarteritis, crescentic glomerulonephritis and Wegener's granulomatosis.

Source page: https://510kreport.com/device/K050715
Methodology: https://510kreport.com/methodology