Cleared Traditional

K082080 - ALCO TUBE PLUS

K082080 is an FDA 510(k) clearance for ALCO TUBE PLUS, manufactured by Alcotest Quebec. The device is a Class 1 Toxicology device with product code DJZ cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K082080 · Alcotest Quebec · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
252d
Days
Class 1
Risk

K082080 is an FDA 510(k) clearance for the ALCO TUBE PLUS. Classified as Devices, Breath Trapping, Alcohol (product code DJZ), Class I - General Controls.

Submitted by Alcotest Quebec (Crofton, US). The FDA issued a Cleared decision on April 1, 2009 after a review of 252 days - an extended review 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: 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.

FDA 510(k) Submission Details - K082080

510(k) Number K082080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2008
Decision Date April 01, 2009
Days to Decision 252 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
165d slower than avg
Panel avg: 87d · This submission: 252d
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 K082080.
MISSION BREATH ALCOHOL DETECTOR
K093143 · ACON Laboratories, Inc. · Jan 2010
ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579
K091714 · Skyfine Inc. Limited · Nov 2009
LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER
K090766 · Lifeloc Technologies, Inc. · Jul 2009
BACTRACK SELECT BREATHALYZER, MODEL S80
K090067 · Khn Solutions, LLC · Mar 2009
BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70
K083801 · Khn Solutions, LLC · Mar 2009
IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS)
K081855 · Canada, Inc. · Dec 2008
K082080 · ALCO TUBE PLUS
Download PDF FDA Summary Alcotest Quebec