Cleared Traditional

K140224 - EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K140224 · Euroimmun US · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
210d slower than avg
Panel avg: 104d · This submission: 314d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.