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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 89d · 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 27
Devices cleared under the same product code (DJZ) and FDA review panel - the closest regulatory comparables to K071067.
ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR
K080848 · Q3 Innovations, LLC · Jul 2008
DRAEGER ALCOTEST 6510
K063443 · Drager Safety · Mar 2008
REDLINE ALCOHOL BREATH TESTER
K072953 · Redline Products (Pty) , Ltd. · Jan 2008
RMI LCD ALCOHOL DETECTOR
K062545 · Resource Management International, LLC · Apr 2007
BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS
K062971 · Akers Biosciences, Inc. · Dec 2006
BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000
K061922 · Sentech Korea Corp. · Oct 2006
K071067 · BACTRACK LCD ALCOHOL DETECTOR
Download PDF FDA Summary Khn Solutions, LLC