Cleared Traditional

K092601 - IMMULISA ANCA SCREEN ELISA

K092601 is an FDA 510(k) clearance for IMMULISA ANCA SCREEN ELISA, manufactured by Immco Diagnostics, Inc.. The device is a Class 2 Immunology device with product code MOB cleared through the Traditional 510(k) pathway after a 409-day FDA review.

K092601 · Immco Diagnostics, Inc. · Immunology device
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Oct 2010
Decision
409d
Days
Class 2
Risk

K092601 is an FDA 510(k) clearance for the IMMULISA ANCA SCREEN ELISA. Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on October 7, 2010 after a review of 409 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Immco Diagnostics, Inc. devices

FDA 510(k) Submission Details - K092601

510(k) Number K092601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2009
Decision Date October 07, 2010
Days to Decision 409 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
305d slower than avg
Panel avg: 104d · This submission: 409d
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 45
Devices cleared under the same product code (MOB) and FDA review panel - the closest regulatory comparables to K092601.
QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM
K112545 · Inova Diagnostics, Inc. · Jul 2012
IMMULISA MPO ANTIBODY ELISA
K092599 · Immco Diagnostics, Inc. · Oct 2010
IMMULISA PR3 ANTIBODY ELISA
K092600 · 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