Cleared Traditional

K040953 - AESKULISA ANA HEP-2

K040953 is an FDA 510(k) clearance for AESKULISA ANA HEP-2, manufactured by Aesku, Inc.. The device is a Class 2 Immunology device with product code LJM cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K040953 · Aesku, Inc. · Immunology device
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Jun 2004
Decision
72d
Days
Class 2
Risk

K040953 is an FDA 510(k) clearance for the AESKULISA ANA HEP-2. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Aesku, Inc. (Miami, US). The FDA issued a Cleared decision on June 23, 2004 after a review of 72 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 - K040953

510(k) Number K040953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2004
Decision Date June 23, 2004
Days to Decision 72 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
33d faster than avg
Panel avg: 105d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJM Device Classification - Class 2, Special Controls

Product Code LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls
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 - LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls

All 107
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K040953.
VARELISA RECOMBI CTD SCREEN, MODEL 13096
K050967 · Sweden Diagnostics (Germany) GmbH · Jun 2005
VARELISA RECOMBI ANA PROFILE, MODEL 18496
K050625 · Sweden Diagnostics (Germany) GmbH · Apr 2005
IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA
K041102 · Immco Diagnostics, Inc. · Oct 2004
VARELISA HISTONE ANTIBODIES, MODEL 16496
K040810 · Pharmacia Deutschland GmbH · May 2004
EL-ANA PROFILES: ANTI-CHROMATIN
K040291 · Theratest Laboratories, Inc. · Mar 2004
MESACUP-2 TEST CENP-B
K040200 · Rhigene, Inc. · Mar 2004
K040953 · AESKULISA ANA HEP-2
Download PDF Aesku, Inc.