Cleared Traditional

K863442 - UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE

K863442 is an FDA 510(k) clearance for UBI MAGIWEL(TM) LH QUANTITATIVE & QUALI..., manufactured by United Biotech, Inc.. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K863442

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 88d · This submission: 152d
Pathway characteristics
Predicate-based equivalence.

CEP Device Classification - Class 1, General Controls

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 101
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K863442.
LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE
K872727 · Serono Diagnostics, Inc. · Aug 1987
MICROCHECK LH OVULATION TEST
K871602 · Syntron Bioresearch, Inc. · Jun 1987
DPC COAT-A-COUNT IRMA LH KIT
K863934 · Diagnostic Products Corp. · Feb 1987
LUTEINIZING HORMONE (LH-IRMA) RIA KIT
K864144 · Immuchem Corp. · Nov 1986
TERUMO SENSIBEAD(TM) EIA HLH KIT
K863929 · Terumo Medical Corp. · Nov 1986
ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM
K863679 · Nichols Institute Diagnostics · Oct 1986