Cleared Traditional

K041040 - VARELISA MPO ANCA, MODEL 17648/17696

K041040 is an FDA 510(k) clearance for VARELISA MPO ANCA, manufactured by Sweden Diagnostics (Germany) GmbH. The device is a Class 2 Immunology device with product code MOB cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K041040 · Sweden Diagnostics (Germany) GmbH · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
55d
Days
Class 2
Risk

K041040 is an FDA 510(k) clearance for the VARELISA MPO ANCA, MODEL 17648/17696. Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Sweden Diagnostics (Germany) GmbH (Freiburg, DE). The FDA issued a Cleared decision on June 16, 2004 after a review of 55 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K041040

510(k) Number K041040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2004
Decision Date June 16, 2004
Days to Decision 55 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
50d faster than avg
Panel avg: 105d · This submission: 55d
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 K041040.
WIESLAB CAP PR-3 ANCA
K051458 · 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
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM
K040111 · Zeus Scientific, Inc. · Apr 2004
MESACUP TEST PR-3
K040711 · Rhigene, Inc. · Apr 2004
MESACUP TEST MPO, MODEL 11053
K040586 · Rhigene, Inc. · Mar 2004
K041040 · VARELISA MPO ANCA, MODEL 17648/17696
Download PDF FDA Summary Sweden Diagnostics (G…