# K050286: Fidis Connective 8

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Diagnostics (Bmd) SA
- Decided: Oct 3, 2005 after 238 days
- Product code: LLL (Extractable Antinuclear 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The FIDIS TM CONNECTIVE 8* kit is a semi-quantitative homogeneous fluorescent-based inicroparticles immunoassay using flow cytometery readings. It is designed for the simultaneous detection of 8 autoantibody specificities: double stranded DNA (dsDNA), SSA 60 kDa, SSA 52 kDa, SSB, Sm, SmN,'R'N, ScI70 and Jo- I *antibodies to dsDNA, Sm, Sm/"RNP, SS-A, SS-B, Scl-70 and Jo-I can be reported using this assay). Clinical utility: The test system is used to screen serum samples and detect the presence of anti-nuclear antibodies associated with connective diseases, systemic lupus erythematosus (SLE), Sjogren's syndrome, mixed connective tissue disease (MCI[)? scleroderma, dennatomyositis, polyinyositis in conjunction with clinical findings and other laboratory tests.

Source page: https://510kreport.com/device/K050286
Methodology: https://510kreport.com/methodology