# K231616: ZEUS IFA (TM) nDNA Test System, ZEUS dIFine

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific
- Decided: Aug 31, 2023 after 90 days
- Product code: KTL (Anti-Dna Indirect Immunofluorescent Solid Phase)
- 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
The ZEUS IFA™ nDNA Test System is an indirect immunofluorescence assay utilizing Crithidia luciliae for the qualitative and semi-quantitative determination of anti-native DNA (nDNA) IgG antibodies to DNA in human serum by manual fluorescence microscopy or with ZEUS dIFine®. The presence of nDNA antibodies in conjunction with other serological and clinical findings can be used to aid in the diagnosis of systemic lupus erythematosus (SLE).

Source page: https://510kreport.com/device/K231616
Methodology: https://510kreport.com/methodology