Cleared Traditional

K902897 - UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE

K902897 is an FDA 510(k) clearance for UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE, manufactured by United Biotech, Inc.. The device is a Class 2 Immunology device with product code LRM cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K902897 · United Biotech, Inc. · Immunology device
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Jul 1990
Decision
13d
Days
Class 2
Risk

K902897 is an FDA 510(k) clearance for the UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE. Classified as Anti-dna Antibody (enzyme-labeled), Antigen, Control (product code LRM), Class II - Special Controls.

Submitted by United Biotech, Inc. (Mountain View, US). The FDA issued a Cleared decision on July 16, 1990 after a review of 13 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

FDA 510(k) Submission Details - K902897

510(k) Number K902897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1990
Decision Date July 16, 1990
Days to Decision 13 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 105d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRM Device Classification - Class 2, Special Controls

Product Code LRM Anti-dna Antibody (enzyme-labeled), Antigen, 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 - LRM Anti-dna Antibody (enzyme-labeled), Antigen, Control

All 19
Devices cleared under the same product code (LRM) and FDA review panel - the closest regulatory comparables to K902897.
VARELISA COMBINED DNA ANTIBODIES EIA
K944334 · Elias U.S.A., Inc. · Apr 1995
VARELISA DSDNA ANTIBODIES (FARR VERSION)
K950031 · Elias U.S.A., Inc. · Mar 1995
ANTI-DNA MICROASSAY
K912020 · Diamedix Corp. · Sep 1991
ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS)
K893036 · Amersham Corp. · Jun 1989