Cleared Traditional

K041753 - AESKULISA ENA 6 S

K041753 is an FDA 510(k) clearance for AESKULISA ENA 6 S, manufactured by Aesku Diagnostics. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K041753 · Aesku Diagnostics · Immunology device
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Jul 2004
Decision
15d
Days
Class 2
Risk

K041753 is an FDA 510(k) clearance for the AESKULISA ENA 6 S. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Aesku Diagnostics (Miami, US). The FDA issued a Cleared decision on July 14, 2004 after a review of 15 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K041753

510(k) Number K041753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2004
Decision Date July 14, 2004
Days to Decision 15 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
90d faster than avg
Panel avg: 105d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLL Device Classification - Class 2, Special Controls

Product Code LLL Extractable Antinuclear 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 - LLL Extractable Antinuclear Antibody, Antigen And Control

All 173
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K041753.
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