# K071210: Modification to Fidis Connective 10*, Model MX006

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Diagnostics (Bmd) SA
- Decided: Dec 19, 2007 after 232 days
- Product code: LKO (Anti-Rnp 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
Longest line of descent: 3 generations back to K000312 (2000). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053653: Fidis Connective 10, Model MX006, Biomedical Diagnostics (Bmd) SA (2006) Summary page 3.

## Most influential descendants
- K102607: Fidistm Connective 10, Fidistm Analyzer, Caris (2010), 0 descendants of its own

## Indications for use
The FIDISTM CONNECTIVE 10* kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry. The test system is used to simultaneously detect the presence of 10 autoantibody specificities: double stranded DNA (dsDNA), SSA (60 kDa and 52 kDa), SSB, Sm, SmnRNP, Scl7O, Jol, ribosome and centromere. (*Antibodies to dsDNA, Sm, Sm/RNJ'P, SSA, SSB, Scl-70, Jo-], ribosome and centromere can be reported using this assay). Clinical utili The results of the FIDISTM CONNECTIVE 10* are to be used in conjunction with the clinical findings and the other laboratory tests to aid in the diagnosis of connective diseases (systemic lupus erythematosus (SLE), Sjogren's syndrome, mixed connective tissue disease (MCTD), scleroderma, dermatomyositis and CREST syndrome). FIDISTM CONNECTIVE 10* kit uses serum only, and is to be run on the FIDISTm Instrument and MLX-BOOSTERTM Software. FIDIS Tm CONNECTIVE 10* kit may be used with the CARISTh system (diluting and dispensing device). This test is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K071210
Methodology: https://510kreport.com/methodology