Cleared Traditional

K060343 - BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000

K060343 is an FDA 510(k) clearance for BREATH ALCOHOL TEST SYSTEM, manufactured by Sentech Korea Corp.. The device is a Class 1 Toxicology device with product code DJZ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K060343 · Sentech Korea Corp. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
90d
Days
Class 1
Risk

K060343 is an FDA 510(k) clearance for the BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000. Classified as Devices, Breath Trapping, Alcohol (product code DJZ), Class I - General Controls.

Submitted by Sentech Korea Corp. (Palisades Park, US). The FDA issued a Cleared decision on May 11, 2006 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3050 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K060343

510(k) Number K060343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2006
Decision Date May 11, 2006
Days to Decision 90 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 87d · This submission: 90d
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 K060343.
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
BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS
K060761 · Akers Biosciences, Inc. · Apr 2006
POCKET BREATHALYZER. CONNECTABLES
K052448 · Connectables, LLC · Feb 2006
BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500
K053332 · Sentech Korea Corp. · Jan 2006
K060343 · BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000
Download PDF FDA Summary Sentech Korea Corp.