Cleared Traditional

K140224 - EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)

K140224 is an FDA 510(k) clearance for EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG), manufactured by Euroimmun US. The device is a Class 2 Immunology device with product code LKO cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K140224 · Euroimmun US · Immunology device
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Dec 2014
Decision
314d
Days
Class 2
Risk

K140224 is an FDA 510(k) clearance for the EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG). Classified as Anti-rnp Antibody, Antigen And Control (product code LKO), Class II - Special Controls.

Submitted by Euroimmun US (Morris Plains, US). The FDA issued a Cleared decision on December 9, 2014 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Euroimmun US devices

FDA 510(k) Submission Details - K140224

510(k) Number K140224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2014
Decision Date December 09, 2014
Days to Decision 314 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
209d slower than avg
Panel avg: 105d · This submission: 314d
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 15
Devices cleared under the same product code (LKO) and FDA review panel - the closest regulatory comparables to K140224.
Maverick RNP Assay and Maverick Diagnostic System
K191085 · Genalyte, Inc. · Oct 2019
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