Cleared Special

K031208 - REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001

K031208 is an FDA 510(k) clearance for REAADS IGM ANTI-B2GPI TEST KIT, 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 81-day FDA review.

K031208 · Corgenix, Inc. · Immunology device
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Jul 2003
Decision
81d
Days
Class 2
Risk

K031208 is an FDA 510(k) clearance for the REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001. 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 July 7, 2003 after a review of 81 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 - K031208

510(k) Number K031208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2003
Decision Date July 07, 2003
Days to Decision 81 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
24d faster than avg
Panel avg: 105d · This submission: 81d
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 45
Devices cleared under the same product code (MSV) and FDA review panel - the closest regulatory comparables to K031208.
VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096
K040452 · Pharmacia Deutschland GmbH · May 2004
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
DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M
K031177 · Axis-Shield Diagnostics, Ltd. · Jun 2003
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA
K030397 · Hycor Biomedical , Ltd. · Mar 2003
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA
K022944 · Hycor Biomedical, Inc. · Dec 2002
K031208 · REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001
Download PDF Corgenix, Inc.