# K040711: Mesacup Test PR-3

- Pathway: 510(k) (Traditional)
- Applicant: Rhigene, Inc.
- Decided: Apr 2, 2004 after 15 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 K981029 (1998). 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)
- K981029: Bindazyme Anti-PR3 Enzyme Immunoassay Kit, The Binding Site, Ltd. (1998) Summary page 1.

## Indications for use
The MESACUP TEST PR-3 is a semi-quantitative, enzyme-linked immunosorbent assay (ELISA) for the detection of IgG anti-proteinase III (PR-3) antibodies in human serum. The MESACUP TEST PR-3 is intended for in vitro diagnostic use as an aid in the diagnosis of certain systemic vasculitides such as Wegener's granulomatosis. The MESACUP TEST PR-3 is intended to be used by clinical (hospital and reference) laboratories.

Source page: https://510kreport.com/device/K040711
Methodology: https://510kreport.com/methodology