Cleared Traditional

K041002 - FIDIS CELIAC

K041002 is an FDA 510(k) clearance for FIDIS CELIAC, manufactured by Biomedical Diagnostics S.A.. The device is a Class 2 Immunology device with product code MST cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K041002 · Biomedical Diagnostics S.A. · Immunology device
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Sep 2004
Decision
158d
Days
Class 2
Risk

K041002 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 S.A. (Marne-La-Vallee, Cedex 2, FR). The FDA issued a Cleared decision on September 24, 2004 after a review of 158 days - an extended review cycle.

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 S.A. devices

FDA 510(k) Submission Details - K041002

510(k) Number K041002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2004
Decision Date September 24, 2004
Days to Decision 158 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
53d slower than avg
Panel avg: 105d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MST Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MST Antibodies, Gliadin

All 31
Devices cleared under the same product code (MST) and FDA review panel - the closest regulatory comparables to K041002.
QUANTA LITE CELIAC DGP SCREEN
K062708 · Inova Diagnostics, Inc. · Dec 2006
QUANTA LITE GLIADIN IGG II
K052142 · Inova Diagnostics, Inc. · Oct 2005
QUANTA LITE GLIADIN IGA II
K052143 · Inova Diagnostics, Inc. · Oct 2005
DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
K012795 · Diamedix Corp. · Sep 2001
DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM
K012797 · Diamedix Corp. · Sep 2001
THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR
K001393 · Zeus Scientific, Inc. · Jun 2000