Cleared Traditional

K120889 - AESKUSLIDES ANA HEP-2

K120889 is an FDA 510(k) clearance for AESKUSLIDES ANA HEP-2, manufactured by Aesku Diagnostics. The device is a Class 2 Immunology device with product code DHN cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K120889 · Aesku Diagnostics · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
206d
Days
Class 2
Risk

K120889 is an FDA 510(k) clearance for the AESKUSLIDES ANA HEP-2. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Aesku Diagnostics (Pedricktown, US). The FDA issued a Cleared decision on October 15, 2012 after a review of 206 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 Aesku Diagnostics devices

FDA 510(k) Submission Details - K120889

510(k) Number K120889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2012
Decision Date October 15, 2012
Days to Decision 206 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
102d slower than avg
Panel avg: 104d · This submission: 206d
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 64
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K120889.
ImmuGlo HEp-2 Elite IFA
K172745 · Immco Diagnostics, Inc. · Jun 2018
EUROIMMUN IFA 40: HEP-20-10
K141827 · Euroimmun Us, Inc. · Apr 2015
NOVA Lite DAPI ANA Kit
K150155 · Inova Diagnostics, Inc. · Apr 2015
RHIGENE HEP-ANA TEST SYSTEM
K042680 · Corgenix, Inc. · Nov 2004
LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130
K024220 · Bio-Rad · Jan 2003
LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108
K024217 · Bio-Rad · Jan 2003