Cleared Traditional

K070458 - MODIFICATION TO FIDIS VASCULITIS, MODEL MX007

K070458 is an FDA 510(k) clearance for MODIFICATION TO 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 308-day FDA review.

K070458 · Biomedical Diagnostics (Bmd) SA · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
308d
Days
Class 2
Risk

K070458 is an FDA 510(k) clearance for the MODIFICATION TO 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 December 21, 2007 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K070458

510(k) Number K070458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2007
Decision Date December 21, 2007
Days to Decision 308 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
203d slower than avg
Panel avg: 105d · This submission: 308d
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
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K070458 · MODIFICATION TO FIDIS VASCULITIS, MODEL MX007
Download PDF FDA Summary Biomedical Diagnostic…