Cleared Traditional

K883355 - UBI MAGIWEL RF-IGM QUANTITATIVE

K883355 is the FDA 510(k) clearance for UBI MAGIWEL RF-IGM QUANTITATIVE by United Biotech, Inc.. It is a Class 2 Immunology device (product code DHR) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K883355 · United Biotech, Inc. · Immunology device
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Sep 1988
Decision
29d
Days
Class 2
Risk

K883355 is an FDA 510(k) clearance for the UBI MAGIWEL RF-IGM QUANTITATIVE. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by United Biotech, Inc. (Mountain View, US). The FDA issued a Cleared decision on September 7, 1988 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5775 - 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 K883355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1988
Decision Date September 07, 1988
Days to Decision 29 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 104d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHR System, Test, Rheumatoid Factor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5775
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 - DHR System, Test, Rheumatoid Factor

All 85
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K883355.
REAADS-RF TEST KIT-QUANTITATIVE
K892444 · Biosearch Medical Products, Inc. · Jun 1989
REAADS-RF TEST KIT-SEMIQUANTITATIVE
K892445 · Biosearch Medical Products, Inc. · Jun 1989
TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
K884180 · Unipath , Ltd. · Feb 1989
QM300 RHEUMATOID FACTOR ANTIGEN PACK
K883536 · Kallestad Diag, A Div. of Erbamont, Inc. · Sep 1988
QM300 CALIBRATOR E PACK
K883538 · Kallestad Diag, A Div. of Erbamont, Inc. · Sep 1988
REUMA TEST
K873782 · Sclavo, Inc. · Nov 1987