# K041043: Varelisa PR3 Anca, Model Number 17748/17796

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia Deutschland GmbH
- Decided: Jul 2, 2004 after 71 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) INOVA QUANTA Lite PR-3: named in the summary without a submission number

## Most influential descendants
- K072358: Bioplex Vasculitis Kit (2007), 0 descendants of its own

## Indications for use
The Varelisa PR3 ANCA EIA kit is designed for the semiquantitative and qualitative determination of proteinase 3 anti neutrophil cytoplasmic antibodies (PR3 ANCA) in human serum or plasma to aid in the diagnosis of Wegener's granulomatosis.

Source page: https://510kreport.com/device/K041043
Methodology: https://510kreport.com/methodology