Cleared Traditional

K951186 - VARELISA ANA-4 SCREEN

K951186 is the FDA 510(k) clearance for VARELISA ANA-4 SCREEN 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 32-day FDA review.

K951186 · Elias U.S.A., Inc. · Immunology device
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Apr 1995
Decision
32d
Days
Class 2
Risk

K951186 is an FDA 510(k) clearance for the VARELISA ANA-4 SCREEN. 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 April 17, 1995 after a review of 32 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 K951186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1995
Decision Date April 17, 1995
Days to Decision 32 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
72d faster than avg
Panel avg: 104d · This submission: 32d
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 38
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K951186.
HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE
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K954380 · Inova Diagnostics, Inc. · Feb 1996
VARELISA ANA PROFILE
K951205 · Elias U.S.A., Inc. · Apr 1995
VARELISA HISTONE ANTIBODIES
K951207 · Elias U.S.A., Inc. · Apr 1995
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K943585 · Immco Diagnostics, Inc. · Jan 1995