Cleared Traditional

K131791 - IFA 40: HEP-20-10

K131791 is an FDA 510(k) clearance for IFA 40: HEP-20-10, manufactured by Euroimmun US. The device is a Class 2 Immunology device with product code DHN cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K131791 · Euroimmun US · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
253d
Days
Class 2
Risk

K131791 is an FDA 510(k) clearance for the IFA 40: HEP-20-10. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Euroimmun US (Morris Plains, US). The FDA issued a Cleared decision on February 26, 2014 after a review of 253 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 devices

FDA 510(k) Submission Details - K131791

510(k) Number K131791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2013
Decision Date February 26, 2014
Days to Decision 253 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
148d slower than avg
Panel avg: 105d · This submission: 253d
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
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K131791.
Image Navigator by Immuno Concepts
K160265 · Immuno Concepts, N.A. , Ltd. · Jun 2016
EUROIMMUN IFA 40: HEP-20-10
K141827 · Euroimmun Us, Inc. · Apr 2015
NOVA Lite DAPI ANA Kit
K150155 · Inova Diagnostics, Inc. · Apr 2015
AESKUSLIDES ANA HEP-2
K120889 · Aesku Diagnostics · Oct 2012
RHIGENE HEP-ANA TEST SYSTEM
K042680 · Corgenix, Inc. · Nov 2004
LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130
K024220 · Bio-Rad · Jan 2003