Cleared Traditional

K050286 - FIDIS CONNECTIVE 8

K050286 is an FDA 510(k) clearance for FIDIS CONNECTIVE 8, manufactured by Biomedical Diagnostics (Bmd) SA. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K050286 · Biomedical Diagnostics (Bmd) SA · Immunology device
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Oct 2005
Decision
238d
Days
Class 2
Risk

K050286 is an FDA 510(k) clearance for the FIDIS CONNECTIVE 8. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Biomedical Diagnostics (Bmd) SA (Marne La Vallee Cedex 2, FR). The FDA issued a Cleared decision on October 3, 2005 after a review of 238 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomedical Diagnostics (Bmd) SA devices

FDA 510(k) Submission Details - K050286

510(k) Number K050286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2005
Decision Date October 03, 2005
Days to Decision 238 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 105d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLL Device Classification - Class 2, Special Controls

Product Code LLL Extractable Antinuclear Antibody, Antigen And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - LLL Extractable Antinuclear Antibody, Antigen And Control

All 138
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