Cleared Traditional

K113020 - IMMULISA ENHANCED (TM) CARDIOLIPIN IGA

K113020 is an FDA 510(k) clearance for IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, manufactured by Immco Diagnostics, Inc.. The device is a Class 2 Immunology device with product code MID cleared through the Traditional 510(k) pathway after a 380-day FDA review.

K113020 · Immco Diagnostics, Inc. · Immunology device
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Oct 2012
Decision
380d
Days
Class 2
Risk

K113020 is an FDA 510(k) clearance for the IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (AC.... Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on October 25, 2012 after a review of 380 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Immco Diagnostics, Inc. devices

FDA 510(k) Submission Details - K113020

510(k) Number K113020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2011
Decision Date October 25, 2012
Days to Decision 380 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
276d slower than avg
Panel avg: 104d · This submission: 380d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MID Device Classification - Class 2, Special Controls

Product Code MID System, Test, Anticardiolipin Immunological
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 - MID System, Test, Anticardiolipin Immunological

All 72
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K113020.
ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
K131821 · Phadia US, Inc. · Dec 2013
BIOPLEX 2200 APLS IGM
K130528 · Bio-Rad Laboratories · Oct 2013
QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA
K120817 · Inova Diagnostics, Inc. · Feb 2013
BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS
K103834 · Bio-Rad Laboratories · Mar 2012
ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM
K102425 · Zeus Scientific, Inc. · Dec 2011
CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
K091845 · Phadia US, Inc. · Jun 2010