Cleared Traditional

K000752 - RHIGENE MESACUP2 TEST- RNP

K000752 is an FDA 510(k) clearance for RHIGENE MESACUP2 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 62-day FDA review.

K000752 · Rhigene, Inc. · Immunology device
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May 2000
Decision
62d
Days
Class 2
Risk

K000752 is an FDA 510(k) clearance for the RHIGENE MESACUP2 TEST- RNP. 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 May 9, 2000 after a review of 62 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.

FDA 510(k) Submission Details - K000752

510(k) Number K000752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2000
Decision Date May 09, 2000
Days to Decision 62 days
Submission Type Traditional
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
43d faster than avg
Panel avg: 105d · This submission: 62d
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 22
Devices cleared under the same product code (LKO) and FDA review panel - the closest regulatory comparables to K000752.
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
MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006
K071210 · Biomedical Diagnostics (Bmd) SA · Dec 2007
RHIGENE MESACUP-2 TEST RNP, MODEL M7741
K022017 · Rhigene, Inc. · Aug 2002
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
K000752 · RHIGENE MESACUP2 TEST- RNP
Download PDF Rhigene, Inc.