# K180202: Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts

- Pathway: 510(k) (Traditional)
- Applicant: Immuno Concepts, N.A., Ltd.
- Decided: Oct 19, 2018 after 268 days
- Product code: DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control)
- 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 Histofluor Rodent LKS Fluorescent Antibody Test System is intended to be used as an indirect fluorescent antibody test for the qualitative and semi-quantitative detection of autoantibodies associated with autoimmune diseases. It is intended for use with the Image Navigator software and microscope. The results must be interpreted by trained personnel.

Source page: https://510kreport.com/device/K180202
Methodology: https://510kreport.com/methodology