Cleared Traditional

K864174 - UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUALITATIVE

K864174 is an FDA 510(k) clearance for UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUAL..., manufactured by United Biotech, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K864174

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
Combination Product No
PCCP Authorized No
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.

JHI Device Classification - Class 2, Special Controls

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 289
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K864174.
SYNTRON BIORESEARCH EZ CHECK HCG PREGNANCY TEST
K870751 · Syntron Bioresearch, Inc. · 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