Cleared Traditional

K121122 - DETECTABUSE LIQUID CONTROL

K121122 is the FDA 510(k) clearance for DETECTABUSE LIQUID CONTROL by Biochemical Diagnostic, Inc.. It is a Class 1 Chemistry device (product code DIF) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K121122 · Biochemical Diagnostic, Inc. · Chemistry device
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Jul 2012
Decision
81d
Days
Class 1
Risk

K121122 is an FDA 510(k) clearance for the DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Biochemical Diagnostic, Inc. (Edgewood, US). The FDA issued a Cleared decision on July 3, 2012 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3280 - 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: 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 Diagnostic, Inc. devices

Submission Details

510(k) Number K121122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2012
Decision Date July 03, 2012
Days to Decision 81 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 88d · This submission: 81d
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 127
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K121122.
LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
K121143 · Bio-Rad Laboratories · May 2012
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K120504 · Bio-Rad Laboratories, Inc. · Mar 2012
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