Cleared Traditional

K982434 - REAADS IGA ANTI-B2GP 1 TEST KIT

K982434 is an FDA 510(k) clearance for REAADS IGA ANTI-B2GP 1 TEST KIT, manufactured by Corgenix, Inc.. The device is a Class 2 Immunology device with 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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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K982434

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 105d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 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
REAADS IGG ANTI-B2GPI TEST KIT
K982391 · Corgenix, Inc. · Dec 1998
REAADS IGM ANTI-B2GP1 TEST KIT
K982433 · Corgenix, Inc. · Dec 1998
SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY
K982879 · Shield Diagnostics, Ltd. · Oct 1998