Cleared Traditional

EUROIMMUN IFA 40: HEP-20-10 (K141827) - FDA 510(k) Clearance

Also marketed or referenced as:
EUROPATTERN MICROSCOPE AND SOFTWARE

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

K141827 · Euroimmun Us, Inc. · Immunology device
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Apr 2015
Decision
284d
Days
Class 2
Risk

K141827 is an FDA 510(k) clearance for the EUROIMMUN IFA 40: HEP-20-10. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Euroimmun Us, Inc. (Morris Plains, US). The FDA issued a Cleared decision on April 17, 2015 after a review of 284 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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, Inc. devices

Submission Details

510(k) Number K141827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2014
Decision Date April 17, 2015
Days to Decision 284 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
180d slower than avg
Panel avg: 104d · This submission: 284d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, 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.