Cleared Traditional

K020695 - QAB2A IGG ELISA KIT

K020695 is an FDA 510(k) clearance for QAB2A IGG ELISA KIT, manufactured by Cheshire Diagnostics , Ltd.. The device is a Class 2 Immunology device with product code MSV cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K020695 · Cheshire Diagnostics , Ltd. · Immunology device
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Apr 2002
Decision
46d
Days
Class 2
Risk

K020695 is an FDA 510(k) clearance for the QAB2A IGG ELISA KIT. Classified as System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (product code MSV), Class II - Special Controls.

Submitted by Cheshire Diagnostics , Ltd. (Cheshire, GB). The FDA issued a Cleared decision on April 19, 2002 after a review of 46 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cheshire Diagnostics , Ltd. devices

FDA 510(k) Submission Details - K020695

510(k) Number K020695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2002
Decision Date April 19, 2002
Days to Decision 46 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 105d · This submission: 46d
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 36
Devices cleared under the same product code (MSV) and FDA review panel - the closest regulatory comparables to K020695.
DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M
K031177 · Axis-Shield Diagnostics, Ltd. · Jun 2003
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA
K022944 · Hycor Biomedical, Inc. · Dec 2002
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA
K022945 · Hycor Biomedical, Inc. · Dec 2002
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