# K172582: EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern

- Pathway: 510(k) (Traditional)
- Applicant: Euroimmun Us, Inc.
- Decided: May 24, 2018 after 269 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 EUROIMMUN IFA Granulocyte Mosaic EUROPattern is intended as an indirect immunofluorescence test for the qualitative or semi-quantitative determination of immunoglobulin class IgG anti-neutrophil cytoplasmic antibodies (ANCA) in human serum. It is used as an aid in the diagnosis of ANCA associated vasculitides, in conjunction with other laboratory and clinical findings. The EUROIMMUN IFA Granulocyte Mosaic EUROPattern test kit is intended for use with the EUROPattern microscope and software system. All suggested results obtained with the EUROPattern system must be confirmed by trained personnel. The EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern is intended as an indirect immunofluorescence test for the qualitative or semi-quantitative determination of immunoglobulin class IgG anti-neutrophil cytoplasmic antibodies (ANCA) and the qualitative determination of IgG anti-PR3, anti-MPO, and, if included, anti-GBM antibodies in human serum. It is used as an aid in the diagnosis of ANCA associated vasculitides, in conjunction with other laboratory and clinical findings. The EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern test kit is intended for use with the EUROPattern microscope and software system. All suggested results obtained with the EUROPattern system must be confirmed by trained personnel.

Source page: https://510kreport.com/device/K172582
Methodology: https://510kreport.com/methodology