Cleared Traditional

K061922 - BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000

K061922 is an FDA 510(k) clearance for BREATH ALCOHOL TEST SYSTEM, manufactured by Sentech Korea Corp.. The device is a Class 1 Chemistry device with product code DJZ cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K061922 · Sentech Korea Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
115d
Days
Class 1
Risk

K061922 is an FDA 510(k) clearance for the BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000. Classified as Devices, Breath Trapping, Alcohol (product code DJZ), Class I - General Controls.

Submitted by Sentech Korea Corp. (Seoul, KR). The FDA issued a Cleared decision on October 30, 2006 after a review of 115 days - within the typical 510(k) review window.

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 - K061922

510(k) Number K061922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2006
Decision Date October 30, 2006
Days to Decision 115 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 89d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 Consultant

Tuv America, Inc.
LAURA DANIELSON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K061922.
BACTRACK LCD ALCOHOL DETECTOR
K071067 · Khn Solutions, LLC · Sep 2007
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-6000
K060343 · Sentech Korea Corp. · May 2006
BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS
K060761 · Akers Biosciences, Inc. · Apr 2006
POCKET BREATHALYZER. CONNECTABLES
K052448 · Connectables, LLC · Feb 2006
K061922 · BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000
Download PDF FDA Summary Sentech Korea Corp.