Cleared Traditional

K113439 - EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) (FDA 510(k) Clearance)

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

K113439 · Euroimmun US · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
508d
Days
Class 2
Risk

K113439 is an FDA 510(k) clearance for the EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG). Classified as Autoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis (product code NIY), Class II - Special Controls.

Submitted by Euroimmun US (Morris Plains, US). The FDA issued a Cleared decision on April 12, 2013 after a review of 508 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Euroimmun US devices

Submission Details

510(k) Number K113439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2011
Decision Date April 12, 2013
Days to Decision 508 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
404d slower than avg
Panel avg: 104d · This submission: 508d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NIY Autoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
Definition Elisa For The Detection Of Anti-sla (soluble Liver Antigen) Antibody Of The Igg Class. Intended To Aid In The Diagnosis Of Conditions With Elevated Levels Of Anti-sla Antibody Including Autoimmune Hepatitis
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.