Cleared Traditional

K863442 - UBI MAGIWEL(TM) LH QUANTITATIVE & QUALI...

K863442 is the FDA 510(k) clearance for UBI MAGIWEL(TM) LH QUANTITATIVE & QUALI... by United Biotech, Inc.. It is a Class 1 Chemistry device (product code CEP) cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K863442 · United Biotech, Inc. · Chemistry device
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Feb 1987
Decision
152d
Days
Class 1
Risk

K863442 is an FDA 510(k) clearance for the UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by United Biotech, Inc. (Mountain View, US). The FDA issued a Cleared decision on February 4, 1987 after a review of 152 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1485 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all United Biotech, Inc. devices

Submission Details

510(k) Number K863442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1986
Decision Date February 04, 1987
Days to Decision 152 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 88d · This submission: 152d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CEP Radioimmunoassay, Luteinizing Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1485
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CEP Radioimmunoassay, Luteinizing Hormone

All 69
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K863442.
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K863934 · Diagnostic Products Corp. · Feb 1987
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K863929 · Terumo Medical Corp. · Nov 1986
ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM
K863679 · Nichols Institute Diagnostics · Oct 1986
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K861354 · Leeco Diagnostics, Inc. · Sep 1986