Cleared Special

K034013 - REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001

K034013 is an FDA 510(k) clearance for REAADS DSDNA QUANTITATIVE TEST KIT, manufactured by Corgenix, Inc.. The device is a Class 2 Immunology device with product code LKJ cleared through the Special 510(k) pathway after a 15-day FDA review.

K034013 · Corgenix, Inc. · Immunology device
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Jan 2004
Decision
15d
Days
Class 2
Risk

K034013 is an FDA 510(k) clearance for the REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001. Classified as Antinuclear Antibody, Antigen, Control (product code LKJ), Class II - Special Controls.

Submitted by Corgenix, Inc. (Westminster, US). The FDA issued a Cleared decision on January 8, 2004 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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 - K034013

510(k) Number K034013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2003
Decision Date January 08, 2004
Days to Decision 15 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
90d faster than avg
Panel avg: 105d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

LKJ Device Classification - Class 2, Special Controls

Product Code LKJ Antinuclear Antibody, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 - LKJ Antinuclear Antibody, Antigen, Control

All 49
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K034013 · REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001
Download PDF Corgenix, Inc.