# K051458: Wieslab Cap PR-3 Anca

- Pathway: 510(k) (Traditional)
- Applicant: Eurodiagnostica
- Decided: Nov 22, 2005 after 173 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. The FDA summary names its predicate without a number.
- (no number) PR-3 ANCA ELISA Kit: named in the summary without a submission number

## Indications for use
The WieslabTM Cap PR3-ANCA is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to proteinase 3 (PR3) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Wegener's granulomatosis. The assay is intended for use in patients with signs and symptoms consistent with WG. It is not intended for screening a healthy population. The analysis should be performed by trained laboratory professionals.

Source page: https://510kreport.com/device/K051458
Methodology: https://510kreport.com/methodology