Fidis Connective 10*, Model MX006

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Modification to Fidis Connective 10*, Model MX006

510(k) Number

K071210 ↗

FDA Product Code

LKO

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Fidis Connective 10, Model MX006

  Class II

  FDA 510(k) K053653 Active Cleared 13 Mar 2006

• Fidistm Connective 10, Fidistm Analyzer, Caris

  Class II

  FDA 510(k) K102607 Active Cleared 3 Dec 2010

• Fidis Dsdna

  Class II

  FDA 510(k) K060380 Active Cleared 2 May 2006

• Fidis Tm Thyro, Model MX002

  Class II

  FDA 510(k) K061794 Active Cleared 21 Nov 2006

• Modification to Fidis Vasculitis, Model MX007

  Class II

  FDA 510(k) K070458 Active Cleared 21 Dec 2007

• Fidis Celiac

  Class II

  FDA 510(k) K053383 Active Cleared 29 Mar 2006

See all devices from Biomedical Diagnostics (Bmd) SA →

• What clinical settings is this device intended for, and how does it differ from standard antibody testing methods?

  This device, the Fidis Connective 10* (Model MX006), is specifically designed for routine laboratory and blood donor settings, where retrospective clinical samples are analyzed to establish assay thresholds. Unlike traditional single-antigen testing, it enables semi-quantitative detection of autoantibodies against *ten specific antigens simultaneously* in a single assay, streamlining workflows for immunology diagnostics. This makes it particularly useful for high-throughput environments where multiple antibody specificities need to be screened efficiently.

• Is this a single-use kit, and if so, what does that mean for my workflow?

  Yes, the Fidis Connective 10* kit is supplied as a single-use device, meaning each kit is intended for one use only. This design eliminates the need for reprocessing or sterilization between tests, reducing contamination risks and simplifying inventory management. You’ll need to order a new kit for each batch of samples, ensuring consistent performance without carryover risks from prior use.

• What regulatory pathway was followed for this device, and how does that affect its use?

  This modification was cleared via the FDA’s 510(k) traditional pathway, determined to be substantially equivalent to a predicate device under product code LKO (In Vitro Diagnostic Reagents for Immunology). The clearance was reviewed by the Immunology (IM) Advisory Committee, confirming its compliance with Class II medical device regulations (866.5100). Clinically, this means it meets FDA standards for safety and performance in immunology diagnostics, though you should always verify local compliance requirements.

• Are there specific storage requirements for this kit, and how should it be handled?

  While the provided data doesn’t specify storage conditions, single-use immunoassay kits like this typically require protection from extreme temperatures, light, and humidity. Check the included instructions for the manufacturer’s recommended storage (e.g., refrigeration or room temperature) and expiration dates. Always store it in its original packaging until use to preserve sterility and functionality, as improper handling could compromise assay accuracy.

• What antigens does this kit test for, and why might a clinician choose it over other options?

  The kit detects autoantibodies against ten specific antigens, though the exact antigens aren’t listed in the provided data. Clinicians often select this device for simultaneous multi-antigen screening, reducing the need for multiple separate tests. This is particularly valuable in autoimmune disease workups (e.g., systemic lupus erythematosus or mixed connective tissue disease) or blood donor screening, where efficiency and comprehensive profiling are critical. Its semi-quantitative design also provides more nuanced results than qualitative tests.