Cleared Traditional

K864174 - UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUAL...

K864174 is the FDA 510(k) clearance for UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUAL... by United Biotech, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K864174 · United Biotech, Inc. · Chemistry device
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Mar 1987
Decision
140d
Days
Class 2
Risk

K864174 is an FDA 510(k) clearance for the UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUALITATIVE. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by United Biotech, Inc. (Mountain View, US). The FDA issued a Cleared decision on March 13, 1987 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - 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 K864174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1986
Decision Date March 13, 1987
Days to Decision 140 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 88d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
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 Chemistry devices follow this clearance model.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 183
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K864174.
ABBOTT TESTPACK HCG COMBO
K870739 · Abbott Laboratories · May 1987
TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY
K870521 · Hybritech, Inc. · Apr 1987
ACA HUMAN CHORIONIC GONADOTROPIN (HCG) METHOD
K870672 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1987
COAT-A-COUNT IRMA HCG KIT AND ITS COMPONENTS
K870106 · Diagnostic Products Corp. · Mar 1987
TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY
K865057 · Hybritech, Inc. · Mar 1987
VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044
K870259 · Leeco Diagnostics, Inc. · Mar 1987