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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 41
Devices cleared under the same product code (MST) and FDA review panel - the closest regulatory comparables to K041002.
IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02
K052793 · Pharmacia Diagnostics AB · Feb 2006
QUANTA LITE GLIADIN IGG II
K052142 · Inova Diagnostics, Inc. · Oct 2005
QUANTA LITE GLIADIN IGA II
K052143 · Inova Diagnostics, Inc. · Oct 2005
VARELISA GLIADIN IGG ANTIBODIES
K041357 · Sweden Diagnostics (Germany) GmbH · Aug 2004
VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896
K041354 · Sweden Diagnostics (Germany) GmbH · Jul 2004
DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
K012795 · Diamedix Corp. · Sep 2001
K041002 · FIDIS CELIAC
Download PDF FDA Summary Biomedical Diagnostic…