Cleared Traditional

K982434 - REAADS IGA ANTI-B2GP 1 TEST KIT

K982434 is the FDA 510(k) clearance for REAADS IGA ANTI-B2GP 1 TEST KIT by Corgenix, Inc.. It is a Class 2 Immunology device (product code MSV) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K982434 · Corgenix, Inc. · Immunology device
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Dec 1998
Decision
161d
Days
Class 2
Risk

K982434 is an FDA 510(k) clearance for the REAADS IGA ANTI-B2GP 1 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 December 22, 1998 after a review of 161 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 K982434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1998
Decision Date December 22, 1998
Days to Decision 161 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
57d slower than avg
Panel avg: 104d · This submission: 161d
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 K982434.
VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT
K992224 · Hemagen Diagnostics, Inc. · Aug 1999
VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT
K992241 · Hemagen Diagnostics, Inc. · Aug 1999
VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT
K992243 · Hemagen Diagnostics, Inc. · Aug 1999
QUANTA LITE B2 GPI SCREEN
K980230 · Inova Diagnostics, Inc. · Mar 1998
QUANTA LITE B2 GPI IGA
K973006 · Inova Diagnostics, Inc. · Oct 1997
QUANTA LITE B2GPI IGM
K973014 · Inova Diagnostics, Inc. · Oct 1997