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)
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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.

View all Sentech Korea Corp. devices

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
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 88d · 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 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 K061922.
PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE
K123470 · Pas Systems International, Inc. · Apr 2013
PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM
K110614 · Seju Engineering Co., Ltd. · Nov 2011
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