Cleared Special

K022018 - RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560

K022018 is an FDA 510(k) clearance for RHIGENE ANA ELISA TEST SYSTEM, manufactured by Rhigene, Inc.. The device is a Class 2 Immunology device with product code LJM cleared through the Special 510(k) pathway after a 15-day FDA review.

K022018 · Rhigene, Inc. · Immunology device
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Jul 2002
Decision
15d
Days
Class 2
Risk

K022018 is an FDA 510(k) clearance for the RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Rhigene, Inc. (Des Plaines, US). The FDA issued a Cleared decision on July 5, 2002 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 - K022018

510(k) Number K022018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2002
Decision Date July 05, 2002
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.

LJM Device Classification - Class 2, Special Controls

Product Code LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls
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 - LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls

All 107
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K022018.
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K004019 · The Binding Site, Ltd. · Feb 2001
QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA
K003959 · Inova Diagnostics, Inc. · Jan 2001
EL-ANA PROFILES-2K1
K002559 · Theratest Laboratories, Inc. · Sep 2000
K022018 · RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560
Download PDF Rhigene, Inc.