# K041040: Varelisa Mpo Anca, Model 17648/17696

- Pathway: 510(k) (Traditional)
- Applicant: Sweden Diagnostics (Germany) GmbH
- Decided: Jun 16, 2004 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.
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 MPO: 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 MPO ANCA EIA kit is designed for the semi-quantitative and qualitative determination of myeloperoxidase anti neutrophil cytoplasmatic antibodies (MPO ANCA) in human serum or plasma to aid in the diagnosis of certain autoimlune vasculitides such as microscopic polyangiitis, and crescentic glomerulonephritis.

Source page: https://510kreport.com/device/K041040
Methodology: https://510kreport.com/methodology