# K203599: Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System

- Pathway: 510(k) (Traditional)
- Applicant: Immuno Concepts, N.A., Ltd.
- Decided: May 26, 2023 after 898 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 Immuno Concepts IgG Anti-nDNA Fluorescent Test System is for in vitro diagnostic use for the qualitative detection and semi-quantitation of anti-nDNA antibodies of the IgG class in human serum by manual fluorescent microscopy or with the Image Navigator@ Fluorescence Semiautomated Microscope. The Immuno Concepts IgG Anti-nDNA Fluorescent Test System is to be used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE) in conjunction with other clinical and laboratory findings. A trained operator must confirm results generated with the Image Navigator@ semi-automated device and software.

Source page: https://510kreport.com/device/K203599
Methodology: https://510kreport.com/methodology