Cleared Traditional

K072032 - IGG ANTI-ATHEROX TEST KIT

K072032 is the FDA 510(k) clearance for IGG ANTI-ATHEROX TEST KIT by Corgenix, Inc.. It is a Class 2 Immunology device (product code MSV) cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K072032 · Corgenix, Inc. · Immunology device
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Apr 2008
Decision
255d
Days
Class 2
Risk

K072032 is an FDA 510(k) clearance for the IGG ANTI-ATHEROX TEST KIT. Classified as System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (product code MSV), Class II - Special Controls.

Submitted by Corgenix, Inc. (Broomfield, US). The FDA issued a Cleared decision on April 4, 2008 after a review of 255 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 Corgenix, Inc. devices

Submission Details

510(k) Number K072032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2007
Decision Date April 04, 2008
Days to Decision 255 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
151d slower than avg
Panel avg: 104d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MSV System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
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 - MSV System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)

All 23
Devices cleared under the same product code (MSV) and FDA review panel - the closest regulatory comparables to K072032.
QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls
K152875 · Inova Diagnostics, Inc. · Dec 2015
QUANTA FLASH ¿2GP1-DOMAIN1
K141274 · Inova Diagnostics, Inc. · Feb 2015
HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I
K091556 · Instrumentation Laboratory CO · May 2010
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA
K030701 · Immco Diagnostics, Inc. · Sep 2003
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA
K030702 · Immco Diagnostics, Inc. · Sep 2003
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA
K022944 · Hycor Biomedical, Inc. · Dec 2002