Cleared Traditional

K110614 - PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM

K110614 is an FDA 510(k) clearance for PAD (PERSONAL ALCOHOL DETECTOR) BREATH ..., manufactured by Seju Engineering Co., Ltd.. The device is a Class 1 Chemistry device with product code DJZ cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K110614 · Seju Engineering Co., Ltd. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
263d
Days
Class 1
Risk

K110614 is an FDA 510(k) clearance for the PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM. Classified as Devices, Breath Trapping, Alcohol (product code DJZ), Class I - General Controls.

Submitted by Seju Engineering Co., Ltd. (Yuseong-Gu, Daejeon, KR). The FDA issued a Cleared decision on November 21, 2011 after a review of 263 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 - K110614

510(k) Number K110614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2011
Decision Date November 21, 2011
Days to Decision 263 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
175d slower than avg
Panel avg: 88d · This submission: 263d
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 K110614.
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K102338 · Akers Biosciences, Inc. · Jan 2011
CONTRALCO
K100879 · Contralco · Aug 2010
MISSION BREATH ALCOHOL DETECTOR
K093143 · ACON Laboratories, Inc. · Jan 2010
K110614 · PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM
Download PDF FDA Summary Seju Engineering Co.,…