Cleared Traditional

K041628 - AESKULISA DS DNA G

K041628 is an FDA 510(k) clearance for AESKULISA DS DNA G, manufactured by Aesku Diagnostics. The device is a Class 2 Immunology device with product code LSW cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K041628 · Aesku Diagnostics · Immunology device
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Oct 2004
Decision
120d
Days
Class 2
Risk

K041628 is an FDA 510(k) clearance for the AESKULISA DS DNA G. Classified as Anti-dna Antibody, Antigen And Control (product code LSW), Class II - Special Controls.

Submitted by Aesku Diagnostics (Miami, US). The FDA issued a Cleared decision on October 14, 2004 after a review of 120 days - within the typical 510(k) review window.

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 - K041628

510(k) Number K041628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2004
Decision Date October 14, 2004
Days to Decision 120 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
16d slower than avg
Panel avg: 104d · This submission: 120d
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 K041628.
AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10
K172348 · Aesku.Diagnostics GmbH & Co. KG · Feb 2018
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