Cleared Traditional

K062971 - BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS

K062971 is an FDA 510(k) clearance for BREATH ALCOHOL CHECK .02 AND BREATHSCAN..., manufactured by Akers Biosciences, Inc.. The device is a Class 1 Toxicology device with product code DJZ cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K062971 · Akers Biosciences, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
80d
Days
Class 1
Risk

K062971 is an FDA 510(k) clearance for the BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS. Classified as Devices, Breath Trapping, Alcohol (product code DJZ), Class I - General Controls.

Submitted by Akers Biosciences, Inc. (Thorofare, US). The FDA issued a Cleared decision on December 18, 2006 after a review of 80 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K062971

510(k) Number K062971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2006
Decision Date December 18, 2006
Days to Decision 80 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
7d faster than avg
Panel avg: 87d · This submission: 80d
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 K062971.
REDLINE ALCOHOL BREATH TESTER
K072953 · Redline Products (Pty) , Ltd. · Jan 2008
BACTRACK LCD ALCOHOL DETECTOR
K071067 · Khn Solutions, LLC · Sep 2007
RMI LCD ALCOHOL DETECTOR
K062545 · Resource Management International, LLC · Apr 2007
BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000
K061922 · Sentech Korea Corp. · Oct 2006
BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000
K060343 · Sentech Korea Corp. · May 2006
BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS
K060761 · Akers Biosciences, Inc. · Apr 2006
K062971 · BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS
Download PDF FDA Summary Akers Biosciences, In…