Cleared Traditional

K053012 - FIDIS VASCULITIS, MODEL MX007

K053012 is an FDA 510(k) clearance for FIDIS VASCULITIS, manufactured by Biomedical Diagnostics (Bmd) SA. The device is a Class 2 Immunology device with product code MOB cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K053012 · Biomedical Diagnostics (Bmd) SA · Immunology device
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Mar 2006
Decision
127d
Days
Class 2
Risk

K053012 is an FDA 510(k) clearance for the FIDIS VASCULITIS, MODEL MX007. Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Biomedical Diagnostics (Bmd) SA (Marne La Vallee Cedex 2, FR). The FDA issued a Cleared decision on March 2, 2006 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - 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 - K053012

510(k) Number K053012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2005
Decision Date March 02, 2006
Days to Decision 127 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 105d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOB Device Classification - Class 2, Special Controls

Product Code MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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 - MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca)

All 74
Devices cleared under the same product code (MOB) and FDA review panel - the closest regulatory comparables to K053012.
MODIFICATION TO FIDIS VASCULITIS, MODEL MX007
K070458 · Biomedical Diagnostics (Bmd) SA · Dec 2007
EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.
K060700 · Euroimmun Us, LLC · Sep 2006
EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3
K061376 · Theratest Laboratories, Inc. · Jul 2006
EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM
K051489 · Euroimmun Us, LLC · Feb 2006
WIESLAB CAP MPO-ANCA
K051455 · Eurodiagnostica · Nov 2005
WIESLAB CAP PR-3 ANCA
K051458 · Eurodiagnostica · Nov 2005
K053012 · FIDIS VASCULITIS, MODEL MX007
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