Cleared Traditional

K141827 - EUROIMMUN IFA 40: HEP-20-10

Also marketed or referenced as:
EUROPATTERN MICROSCOPE AND SOFTWARE

K141827 is an FDA 510(k) clearance for EUROIMMUN IFA 40: HEP-20-10, manufactured by Euroimmun Us, Inc.. The device is a Class 2 Immunology device with product code DHN cleared through the Traditional 510(k) pathway after a 284-day FDA review.

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

FDA 510(k) Submission Details - K141827

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
179d slower than avg
Panel avg: 105d · This submission: 284d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHN Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

All 70
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