Cleared Traditional

K910033 - UBI MAGIWEL(TM) ANA QUANTITATIVE

K910033 is the FDA 510(k) clearance for UBI MAGIWEL(TM) ANA QUANTITATIVE by United Biotech, Inc.. It is a Class 2 Immunology device (product code LJM) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K910033 · United Biotech, Inc. · Immunology device
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Jan 1991
Decision
21d
Days
Class 2
Risk

K910033 is an FDA 510(k) clearance for the UBI MAGIWEL(TM) ANA QUANTITATIVE. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by United Biotech, Inc. (Mountain View, US). The FDA issued a Cleared decision on January 25, 1991 after a review of 21 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 United Biotech, Inc. devices

Submission Details

510(k) Number K910033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1991
Decision Date January 25, 1991
Days to Decision 21 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 104d · This submission: 21d
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 39
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K910033.
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HEMAGEN ENA [RNP/SM] KIT (EIA METHOD)
K915272 · Hemagen Diagnostics, Inc. · Mar 1992
ANTI-SCI-70 MICROASSAY
K902915 · Diamedix Corp. · Sep 1990
ANTI-SM MICROASSAY
K894894 · Diamedix Corp. · Aug 1989
ENZYME ANA TEST SYSTEM
K833148 · Immuno Concepts, Inc. · Nov 1983