# K141827: Euroimmun Ifa 40: Hep-20-10; Europattern Microscope and Software

- Pathway: 510(k) (Traditional)
- Applicant: Euroimmun Us, Inc.
- Decided: Apr 17, 2015 after 284 days
- Product code: DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control)
- Device class: 2
- Regulation: 21 CFR 866.5100
- 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
Instrument: The EUROPattern Microscope and Software is an automated system consisting of fluorescent microscope and software that acquires, interprets, stores and displays digital images of stained indirect immunofluorescence slides. The EUROPattern Microscope and Software can only be used with cleared or approved EUROIMMUN in vitro diagnostic assays that are indicated for use on the device. All suggested results obtained with the EUROPattern Microscope and Software must be confirmed by trained personnel. Assay: The EUROIMMUN IFA 40: HEp-20-10 EUROPattern is an indirect immunofluorescence antibody test for the qualitative or semi-quantitative determination of IgG antibodies against anti-nuclear antibody (ANA) in human serum with the EUROPattern Microscope and Software automated instrument. This in vitro diagnostic assay is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other laboratory and clinical findings. All suggested results obtained with the EUROPattern system must be confirmed by trained personnel.

Source page: https://510kreport.com/device/K141827
Methodology: https://510kreport.com/methodology