Cleared Special

K032868 - REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139

K032868 is an FDA 510(k) clearance for REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUA..., manufactured by Corgenix, Inc.. The device is a Class 2 Immunology device with product code MID cleared through the Special 510(k) pathway after a 29-day FDA review.

K032868 · Corgenix, Inc. · Immunology device
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Oct 2003
Decision
29d
Days
Class 2
Risk

K032868 is an FDA 510(k) clearance for the REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Corgenix, Inc. (Westminster, US). The FDA issued a Cleared decision on October 14, 2003 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - the FDA immunology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K032868

510(k) Number K032868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2003
Decision Date October 14, 2003
Days to Decision 29 days
Submission Type Special
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
76d faster than avg
Panel avg: 105d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 93
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K032868.
HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS
K092181 · Instrumentation Laboratory CO · Mar 2010
EL-ACL SCREEN
K060176 · Theratest Laboratories, Inc. · Feb 2006
AESKULISA CARDIOLIPIN AGM
K040463 · Aesku, Inc. · May 2004
BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT
K032240 · The Binding Site, Ltd. · Sep 2003
AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA
K030741 · Hycor Biomedical , Ltd. · May 2003
MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT
K024195 · Corgenix, Inc. · Jan 2003
K032868 · REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139
Download PDF Corgenix, Inc.