Cleared Traditional

K041043 - VARELISA PR3 ANCA, MODEL NUMBER 17748/17796

K041043 is an FDA 510(k) clearance for VARELISA PR3 ANCA, manufactured by Pharmacia Deutschland GmbH. The device is a Class 2 Immunology device with product code MOB cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K041043 · Pharmacia Deutschland GmbH · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
71d
Days
Class 2
Risk

K041043 is an FDA 510(k) clearance for the VARELISA PR3 ANCA, MODEL NUMBER 17748/17796. Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Pharmacia Deutschland GmbH (Freiburg Im Breisgau, DE). The FDA issued a Cleared decision on July 2, 2004 after a review of 71 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.

View all Pharmacia Deutschland GmbH devices

FDA 510(k) Submission Details - K041043

510(k) Number K041043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2004
Decision Date July 02, 2004
Days to Decision 71 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 105d · This submission: 71d
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 60
Devices cleared under the same product code (MOB) and FDA review panel - the closest regulatory comparables to K041043.
EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)
K082130 · Euroimmun Us, Inc. · Apr 2009
EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3
K061376 · Theratest Laboratories, Inc. · Jul 2006
QUANTA PLEX ANCA PROFILE
K050715 · Inova Diagnostics, Inc. · May 2005
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM
K040111 · Zeus Scientific, Inc. · Apr 2004
RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16
K013283 · Immuno Concepts, Inc. · Nov 2001
RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15
K013285 · Immuno Concepts, Inc. · Nov 2001