Cleared Traditional

K080848 - ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR

K080848 is an FDA 510(k) clearance for ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DE..., manufactured by Q3 Innovations, LLC. The device is a Class 1 Chemistry device with product code DJZ cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K080848 · Q3 Innovations, LLC · Chemistry device
Download Printable Device Report (PDF)
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Jul 2008
Decision
121d
Days
Class 1
Risk

K080848 is an FDA 510(k) clearance for the ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR. Classified as Devices, Breath Trapping, Alcohol (product code DJZ), Class I - General Controls.

Submitted by Q3 Innovations, LLC (Deer Field, US). The FDA issued a Cleared decision on July 25, 2008 after a review of 121 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 Q3 Innovations, LLC devices

FDA 510(k) Submission Details - K080848

510(k) Number K080848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2008
Decision Date July 25, 2008
Days to Decision 121 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
33d slower than avg
Panel avg: 88d · This submission: 121d
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.