Cleared Traditional

K032469 - AESKULISA ANA 8PRO

K032469 is an FDA 510(k) clearance for AESKULISA ANA 8PRO, manufactured by Aesku, Inc.. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K032469 · Aesku, Inc. · Immunology device
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Dec 2003
Decision
127d
Days
Class 2
Risk

K032469 is an FDA 510(k) clearance for the AESKULISA ANA 8PRO. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Aesku, Inc. (Miami, US). The FDA issued a Cleared decision on December 16, 2003 after a review of 127 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, Inc. devices

FDA 510(k) Submission Details - K032469

510(k) Number K032469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2003
Decision Date December 16, 2003
Days to Decision 127 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
22d slower than avg
Panel avg: 105d · This submission: 127d
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 143
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K032469.
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K030681 · Inova Diagnostics, Inc. · Apr 2003
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