# K053653: Fidis Connective 10, Model MX006

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Diagnostics (Bmd) SA
- Decided: Mar 13, 2006 after 73 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
Longest line of descent: 2 generations back to K000312 (2000). 10 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950031: Varelisa Dsdna Antibodies (Farr Version), Elias U.S.A., Inc. (1995) Summary page 1.
- K944169: Varelisa RO (SS-a) Antibodies, Elias U.S.A., Inc. (1994) Summary page 1.
- K944168: Varelisa LA (SS-B) Antibodies, Elias U.S.A., Inc. (1994) Summary page 1.
- K042629: Varelisa SM Antibodies, Model 18296, Sweden Diagnostics (Germany) GmbH (2004) Summary page 1.
- K993589: Varelisa RNP Antibodies, Pharmacia & Upjohn Co. (1999) Summary page 1.
- K944173: Varelisa JO-1 Antibodies, Elias U.S.A., Inc. (1994) Summary page 1.
- K944172: Varelisa SCL-70 Antibodies, Elias U.S.A., Inc. (1994) Summary page 1.
- K944171: Varelisa Centromere Antibodies, Elias U.S.A., Inc. (1994) Summary page 1.
- K981237: Quanta Lite Ribosome P Elisa, Inova Diagnostics, Inc. (1998) Summary page 1.

## Most influential descendants
- K151429: QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols (2016), 2 descendants of its own
- K071210: Modification to Fidis Connective 10*, Model MX006 (2007), 1 descendant of its own
- K213403: Aptiva CTD Essential Reagent (2023), 0 descendants of its own
- K180975: QUANTA Flash HMGCR Reagents (2018), 0 descendants of its own
- 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 readings. It is designed for the simultaneous detection of autoantibody specificities: double stranded DNA (dsDNA), SSA (60 kDA and 52 kDA), SSB, Sm, Sm/RNP, Scl-70, Jo-I ribosome and centromere in human serum. (*Antibodies to dsDNA, SSA, SSB, Sm, Sm/RNP, Scl-70, Jo-1, ribosome and centromere can be reported using this assay). The test system is used to screen serum samples and detect the presence of antinuclear antibodies associated with connective diseases systemic lupus erythematosus (SLE), Sjcgren's syndrome, mixed connective tissue disease (MCTD), scleroderma, dermatomyositis, and CREST syndrome, in conjunction with clinical findings and other laboratory tests.

Source page: https://510kreport.com/device/K053653
Methodology: https://510kreport.com/methodology