# K201956: Zeus IFA ANA HEp-2 Test System, Zeus dIFine

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Apr 29, 2022 after 654 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
Assay: ZEUS IFA™ ANA HEp-2 Test System is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of IgG anti-nuclear antibodies in human serum by manual fluorescence microscopy or with ZEUS dIFine®. The presence of anti-nuclear antibodies can be used in conjunction with other serological tests and clinical findings to aid in the diagnosis of systemic lupus erythematosus and other systemic rheumatic diseases. All suggested results obtained with ZEUS dIFine® must be confirmed by a trained operator. Instrument: ZEUS dIFine® is an automated instrument consisting of a fluorescent microscope and software that acquires, interprets, stores and displays digital images of stained indirect immunofluorescence slides. ZEUS dIFine can only be used with FDA cleared or approved ZEUS in vitro diagnostic assays that are indicated for use on this instrument. All suggested results obtained with ZEUS dIFine must be confirmed by a trained operator

Source page: https://510kreport.com/device/K201956
Methodology: https://510kreport.com/methodology