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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 105d · 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.
MODIFICATION TO AESKULISA DS DNA G
K081251 · Aesku Diagnostics · May 2008
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
K072393 · Phadia US, Inc. · Dec 2007
FIDIS DSDNA
K060380 · Biomedical Diagnostics (Bmd) SA · May 2006
ANTI-DSDNA ANTIBODY TEST
K921658 · Immco Diagnostics, Inc. · Mar 1993