Cleared Traditional

K973155 - UBI MAGIWEL OPIATE METABOLITES

K973155 is an FDA 510(k) clearance for UBI MAGIWEL OPIATE METABOLITES, manufactured by United Biotech, Inc.. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K973155 · United Biotech, Inc. · Toxicology device
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Oct 1997
Decision
67d
Days
Class 2
Risk

K973155 is an FDA 510(k) clearance for the UBI MAGIWEL OPIATE METABOLITES. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by United Biotech, Inc. (Mountain View, US). The FDA issued a Cleared decision on October 28, 1997 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - the FDA toxicology 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

FDA 510(k) Submission Details - K973155

510(k) Number K973155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1997
Decision Date October 28, 1997
Days to Decision 67 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 87d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJG Device Classification - Class 2, Special Controls

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 Toxicology devices follow this clearance model.

Regulatory Peers - DJG Enzyme Immunoassay, Opiates

All 189
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K973155.
ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL
K974840 · Roche Diagnostic Systems, Inc. · Apr 1998
MICRO-STRIP FOR OPIATE METABOLITES
K973761 · Microdiagnostics, Inc. · Dec 1997
UBI MAGIWEL AMPHETAMINE METABOLITES
K973153 · United Biotech, Inc. · Oct 1997
UBI MAGIWEL COCAINE METABOLITES
K973156 · United Biotech, Inc. · Oct 1997
QUIKSTRIP ONE STEP OPIATES TEST
K972571 · Drial Consultants, Inc. · Aug 1997
QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080)
K972619 · Phamatech · Aug 1997