Cleared Traditional

K951993 - UBI MAGIWEL FERRITIN QUANTITATIVE

K951993 is the FDA 510(k) clearance for UBI MAGIWEL FERRITIN QUANTITATIVE by United Biotech, Inc.. It is a Class 2 Immunology device (product code DBF) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K951993 · United Biotech, Inc. · Immunology device
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Jul 1995
Decision
68d
Days
Class 2
Risk

K951993 is an FDA 510(k) clearance for the UBI MAGIWEL FERRITIN QUANTITATIVE. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by United Biotech, Inc. (Mountain View, US). The FDA issued a Cleared decision on July 5, 1995 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5340 - 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 K951993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1995
Decision Date July 05, 1995
Days to Decision 68 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 104d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBF Ferritin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5340
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 - DBF Ferritin, Antigen, Antiserum, Control

All 64
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K951993.
VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)
K973331 · Ortho-Clinical Diagnostics, Inc. · Oct 1997
MODIFICATION OF OPUS FERRITIN TEST SYSTEM
K973202 · Behring Diagnostics, Inc. · Sep 1997
OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT
K963170 · Olympus America, Inc. · Dec 1996
AMERLITE FERRITIN II ASSAY
K952286 · Johnson & Johnson Clinical Diagnostics, Inc. · Jun 1995
N LATEX FERRITIN
K950707 · Behring Diagnostics, Inc. · Mar 1995
AXSYM FERRITIN
K935847 · Abbott Laboratories · Jun 1994