Cleared Traditional

K071067 - BACTRACK LCD ALCOHOL DETECTOR

K071067 is an FDA 510(k) clearance for BACTRACK LCD ALCOHOL DETECTOR, manufactured by Khn Solutions, LLC. The device is a Class 1 Chemistry device with product code DJZ cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K071067 · Khn Solutions, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
151d
Days
Class 1
Risk

K071067 is an FDA 510(k) clearance for the BACTRACK LCD ALCOHOL DETECTOR. Classified as Devices, Breath Trapping, Alcohol (product code DJZ), Class I - General Controls.

Submitted by Khn Solutions, LLC (Deer Field, US). The FDA issued a Cleared decision on September 14, 2007 after a review of 151 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3050 - 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 Khn Solutions, LLC devices

FDA 510(k) Submission Details - K071067

510(k) Number K071067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2007
Decision Date September 14, 2007
Days to Decision 151 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 88d · This submission: 151d
Pathway characteristics
Predicate-based equivalence.

DJZ Device Classification - Class 1, General Controls

Product Code DJZ Devices, Breath Trapping, Alcohol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3050
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 - DJZ Devices, Breath Trapping, Alcohol

All 9
Devices cleared under the same product code (DJZ) and FDA review panel - the closest regulatory comparables to K071067.
PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE
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PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM
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MISSION BREATH ALCOHOL DETECTOR
K093143 · ACON Laboratories, Inc. · Jan 2010
POCKET BREATHALYZER. CONNECTABLES
K052448 · Connectables, LLC · Feb 2006
BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500
K053332 · Sentech Korea Corp. · Jan 2006
BREATHKEY MODEL G10/BREATHKEY MODEL G30X
K052804 · Omega Point Systems, LLC · Dec 2005