Cleared Traditional

K963291 - VARELISA ANA (4) PROFILE

K963291 is the FDA 510(k) clearance for VARELISA ANA (4) PROFILE by Elias U.S.A., Inc.. It is a Class 2 Immunology device (product code LJM) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K963291 · Elias U.S.A., Inc. · Immunology device
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Sep 1996
Decision
40d
Days
Class 2
Risk

K963291 is an FDA 510(k) clearance for the VARELISA ANA (4) PROFILE. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on September 30, 1996 after a review of 40 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.

View all Elias U.S.A., Inc. devices

Submission Details

510(k) Number K963291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1996
Decision Date September 30, 1996
Days to Decision 40 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
64d faster than avg
Panel avg: 104d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 41
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K963291.
THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR.
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ELIAS ANA-HEP-2
K964385 · Elias U.S.A., Inc. · Mar 1997
HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE
K962450 · Hycor Biomedical, Inc. · Nov 1996
QUANTA LITE SSDNA
K954380 · Inova Diagnostics, Inc. · Feb 1996
VARELISA ANA-4 SCREEN
K951186 · Elias U.S.A., Inc. · Apr 1995
VARELISA ANA PROFILE
K951205 · Elias U.S.A., Inc. · Apr 1995