Cleared Traditional

K022017 - RHIGENE MESACUP-2 TEST RNP, MODEL M7741

K022017 is an FDA 510(k) clearance for RHIGENE MESACUP-2 TEST RNP, manufactured by Rhigene, Inc.. The device is a Class 2 Immunology device with product code LKO cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K022017 · Rhigene, Inc. · Immunology device
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Aug 2002
Decision
55d
Days
Class 2
Risk

K022017 is an FDA 510(k) clearance for the RHIGENE MESACUP-2 TEST RNP, MODEL M7741. Classified as Anti-rnp Antibody, Antigen And Control (product code LKO), Class II - Special Controls.

Submitted by Rhigene, Inc. (Des Plaines, US). The FDA issued a Cleared decision on August 14, 2002 after a review of 55 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. 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 Rhigene, Inc. devices

FDA 510(k) Submission Details - K022017

510(k) Number K022017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2002
Decision Date August 14, 2002
Days to Decision 55 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
50d faster than avg
Panel avg: 105d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKO Device Classification - Class 2, Special Controls

Product Code LKO Anti-rnp Antibody, Antigen And 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 - LKO Anti-rnp Antibody, Antigen And Control

All 16
Devices cleared under the same product code (LKO) and FDA review panel - the closest regulatory comparables to K022017.
EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)
K140224 · Euroimmun US · Dec 2014
EUROIMMUN ANTI-NRNP/SM ELISA (IGG)
K123261 · Euroimmun US · Jun 2013
ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01
K083117 · Phadia US, Inc. · May 2009
VARELISA RNP ANTIBODIES
K993589 · Pharmacia & Upjohn Co. · Nov 1999
AUTOSTAT II ANTI-SM/RNP ELISA
K990624 · Cogent Diagnotics , Ltd. · Apr 1999
LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207
K984476 · Bio-Rad · Dec 1998