Cleared Traditional

K051458 - WIESLAB CAP PR-3 ANCA

K051458 is an FDA 510(k) clearance for WIESLAB CAP PR-3 ANCA, manufactured by Eurodiagnostica. The device is a Class 2 Immunology device with product code MOB cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K051458 · Eurodiagnostica · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
173d
Days
Class 2
Risk

K051458 is an FDA 510(k) clearance for the WIESLAB CAP PR-3 ANCA. Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Eurodiagnostica (Frederick, US). The FDA issued a Cleared decision on November 22, 2005 after a review of 173 days - an extended review cycle.

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 - K051458

510(k) Number K051458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2005
Decision Date November 22, 2005
Days to Decision 173 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
68d slower than avg
Panel avg: 105d · This submission: 173d
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 K051458.
FIDIS VASCULITIS, MODEL MX007
K053012 · Biomedical Diagnostics (Bmd) SA · Mar 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
QUANTA PLEX ANCA PROFILE
K050715 · Inova Diagnostics, Inc. · May 2005
VARELISA PR3 ANCA, MODEL NUMBER 17748/17796
K041043 · Pharmacia Deutschland GmbH · Jul 2004
VARELISA MPO ANCA, MODEL 17648/17696
K041040 · Sweden Diagnostics (Germany) GmbH · Jun 2004
K051458 · WIESLAB CAP PR-3 ANCA
Download PDF FDA Summary Eurodiagnostica