Cleared Traditional

K153474 - Detectabuse Liquid Control Urine

K153474 is the FDA 510(k) clearance for Detectabuse Liquid Control Urine by Biochemical Diagnostics, Inc.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K153474 · Biochemical Diagnostics, Inc. · Toxicology device
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Feb 2016
Decision
83d
Days
Class 1
Risk

K153474 is an FDA 510(k) clearance for the Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urin.... Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Biochemical Diagnostics, Inc. (Edgewood, US). The FDA issued a Cleared decision on February 23, 2016 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - 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 Biochemical Diagnostics, Inc. devices

Submission Details

510(k) Number K153474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2015
Decision Date February 23, 2016
Days to Decision 83 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 87d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIF Drug Mixture Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
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 - DIF Drug Mixture Control Materials

All 147
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K153474.
LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
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LIQUICHEK OPIATE CONTROL
K093577 · Bio-Rad Laboratories · Mar 2010
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K080085 · Thermo Fisher Scientific · Apr 2008
CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500
K080183 · Roche Diagnostics Corp. · Mar 2008
ESA LEADCARE II LEAD CONTROL
K063398 · Bionostics, Inc. · Dec 2006