Cleared Traditional

K060700 - EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.

K060700 is an FDA 510(k) clearance for EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ..., 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 177-day FDA review.

K060700 · Euroimmun Us, LLC · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
177d
Days
Class 2
Risk

K060700 is an FDA 510(k) clearance for the EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.. 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 September 8, 2006 after a review of 177 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 - K060700

510(k) Number K060700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2006
Decision Date September 08, 2006
Days to Decision 177 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
72d slower than avg
Panel avg: 105d · This submission: 177d
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 K060700.
IMMULISA ANCA SCREEN ELISA
K092601 · Immco Diagnostics, Inc. · Oct 2010
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