Cleared Traditional

K051489 - EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM

K051489 is an FDA 510(k) clearance for EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP ..., manufactured by Euroimmun Us, LLC. The device is a Class 2 Immunology device with product code MOB cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K051489 · Euroimmun Us, LLC · Immunology device
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Feb 2006
Decision
255d
Days
Class 2
Risk

K051489 is an FDA 510(k) clearance for the EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM. Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Euroimmun Us, LLC (Boonton Twp, US). The FDA issued a Cleared decision on February 16, 2006 after a review of 255 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.

View all Euroimmun Us, LLC devices

FDA 510(k) Submission Details - K051489

510(k) Number K051489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2005
Decision Date February 16, 2006
Days to Decision 255 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 105d · This submission: 255d
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 55
Devices cleared under the same product code (MOB) and FDA review panel - the closest regulatory comparables to K051489.
EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS
K083850 · Euroimmun Us, Inc. · May 2009
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