Cleared Traditional

K172348 - AESKUSLIDES nDNA (Crithidia luciliae)

K172348 is an FDA 510(k) clearance for AESKUSLIDES nDNA (Crithidia luciliae), manufactured by Aesku.Diagnostics GmbH & Co. KG. The device is a Class 2 Immunology device with product code LSW cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K172348 · Aesku.Diagnostics GmbH & Co. KG · Immunology device
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Optimized for regulatory review, auditing and printing
Feb 2018
Decision
197d
Days
Class 2
Risk

K172348 is an FDA 510(k) clearance for the AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) .... Classified as Anti-dna Antibody, Antigen And Control (product code LSW), Class II - Special Controls.

Submitted by Aesku.Diagnostics GmbH & Co. KG (Wendeslheim, DE). The FDA issued a Cleared decision on February 16, 2018 after a review of 197 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 GmbH & Co. KG devices

FDA 510(k) Submission Details - K172348

510(k) Number K172348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2017
Decision Date February 16, 2018
Days to Decision 197 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 104d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LSW Device Classification - Class 2, Special Controls

Product Code LSW Anti-dna Antibody, Antigen And 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 - LSW Anti-dna Antibody, Antigen And Control

Devices cleared under the same product code (LSW) and FDA review panel - the closest regulatory comparables to K172348.
QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls
K152013 · Inova Diagnostics, Inc. · Apr 2016
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
K072393 · Phadia US, Inc. · Dec 2007
ANTI-DSDNA ANTIBODY TEST
K921658 · Immco Diagnostics, Inc. · Mar 1993