Cleared Traditional

K091860 - AESKULISA MPO, MODEL 30-7303US

K091860 is an FDA 510(k) clearance for AESKULISA MPO, manufactured by Aesku Diagnostics. The device is a Class 2 Immunology device with product code MOB cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K091860 · Aesku Diagnostics · Immunology device
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Feb 2010
Decision
249d
Days
Class 2
Risk

K091860 is an FDA 510(k) clearance for the AESKULISA MPO, MODEL 30-7303US. Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Aesku Diagnostics (Wendelsheim, Rheinland, DE). The FDA issued a Cleared decision on February 23, 2010 after a review of 249 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 Aesku Diagnostics devices

FDA 510(k) Submission Details - K091860

510(k) Number K091860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2009
Decision Date February 23, 2010
Days to Decision 249 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
145d slower than avg
Panel avg: 104d · This submission: 249d
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 46
Devices cleared under the same product code (MOB) and FDA review panel - the closest regulatory comparables to K091860.
IMMULISA MPO ANTIBODY ELISA
K092599 · Immco Diagnostics, Inc. · Oct 2010
IMMULISA PR3 ANTIBODY ELISA
K092600 · Immco Diagnostics, Inc. · Oct 2010
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