Cleared Traditional

PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM (K110614) - FDA 510(k) Clearance

Class I Chemistry device.

K110614 · Seju Engineering Co., Ltd. · Chemistry device
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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.

View all Seju Engineering Co., Ltd. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 88d · This submission: 263d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.