Cleared Special

K013079 - REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT

K013079 is an FDA 510(k) clearance for REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA T..., manufactured by Corgenix, Inc.. The device is a Class 2 Immunology device with product code MSV cleared through the Special 510(k) pathway after a 14-day FDA review.

K013079 · Corgenix, Inc. · Immunology device
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Sep 2001
Decision
14d
Days
Class 2
Risk

K013079 is an FDA 510(k) clearance for the REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT. Classified as System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (product code MSV), Class II - Special Controls.

Submitted by Corgenix, Inc. (Westminster, US). The FDA issued a Cleared decision on September 28, 2001 after a review of 14 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.

View all Corgenix, Inc. devices

FDA 510(k) Submission Details - K013079

510(k) Number K013079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2001
Decision Date September 28, 2001
Days to Decision 14 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
91d faster than avg
Panel avg: 105d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

MSV Device Classification - Class 2, Special Controls

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 35
Devices cleared under the same product code (MSV) and FDA review panel - the closest regulatory comparables to K013079.
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN
K013956 · Diamedix Corp. · Jan 2002
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM
K013628 · Diamedix Corp. · Dec 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT
K013077 · Corgenix, Inc. · Sep 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT
K013080 · Corgenix, Inc. · Sep 2001
BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT
K991801 · The Binding Site, Ltd. · May 2000
BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT
K991802 · The Binding Site, Ltd. · May 2000