Cleared Traditional

FIDIS CELIAC (K053383) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K053383 · Biomedical Diagnostics (Bmd) SA · Immunology device
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Mar 2006
Decision
114d
Days
Class 2
Risk

K053383 is an FDA 510(k) clearance for the FIDIS CELIAC. Classified as Antibodies, Gliadin (product code MST), Class II - Special Controls.

Submitted by Biomedical Diagnostics (Bmd) SA (Marne La Vallee Cedex 2, FR). The FDA issued a Cleared decision on March 29, 2006 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5750 - 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

Submission Details

510(k) Number K053383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2005
Decision Date March 29, 2006
Days to Decision 114 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 104d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MST Antibodies, Gliadin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5750
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.