Cleared Traditional

K093143 - MISSION BREATH ALCOHOL DETECTOR

K093143 is an FDA 510(k) clearance for MISSION BREATH ALCOHOL DETECTOR, manufactured by ACON Laboratories, Inc.. The device is a Class 1 Toxicology device with product code DJZ cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K093143 · ACON Laboratories, Inc. · Toxicology device
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Jan 2010
Decision
115d
Days
Class 1
Risk

K093143 is an FDA 510(k) clearance for the MISSION BREATH ALCOHOL DETECTOR. Classified as Devices, Breath Trapping, Alcohol (product code DJZ), Class I - General Controls.

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on January 28, 2010 after a review of 115 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.

View all ACON Laboratories, Inc. devices

FDA 510(k) Submission Details - K093143

510(k) Number K093143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2009
Decision Date January 28, 2010
Days to Decision 115 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
28d slower than avg
Panel avg: 87d · This submission: 115d
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.