# K060380: Fidis Dsdna

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Diagnostics (Bmd) SA
- Decided: May 2, 2006 after 77 days
- Product code: LSW (Anti-Dna Antibody, Antigen And 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. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K950011: Cohort (TM) Anterior Plate System (Aps), Cohort Medical Products Group, Inc. (1995). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The FIDIS™ dsDNA kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings. It is designed for the detection of antibodies directed against double stranded DNA (dsDNA) The test system is used on serum samples as an aid in the diagnostic of systemic lupus erythematosus (SLE), in conjunction with clinical findings and other laboratory tests. The FIDIS™ dsDNA kit is to be used on FIDIS™ Analyzer, software and washer.

Source page: https://510kreport.com/device/K060380
Methodology: https://510kreport.com/methodology