Cleared Traditional

K093879 - MISSION SALIVA ALCOHOL TEST STRIP

K093879 is an FDA 510(k) clearance for MISSION SALIVA ALCOHOL TEST STRIP, manufactured by ACON Laboratories, Inc.. The device is a Class 2 Toxicology device with product code DIC cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K093879 · ACON Laboratories, Inc. · Toxicology device
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Aug 2010
Decision
231d
Days
Class 2
Risk

K093879 is an FDA 510(k) clearance for the MISSION SALIVA ALCOHOL TEST STRIP. Classified as Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (product code DIC), Class II - Special Controls.

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on August 6, 2010 after a review of 231 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3040 - 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 - K093879

510(k) Number K093879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2009
Decision Date August 06, 2010
Days to Decision 231 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
144d slower than avg
Panel avg: 87d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIC Device Classification - Class 2, Special Controls

Product Code DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

All 29
Devices cleared under the same product code (DIC) and FDA review panel - the closest regulatory comparables to K093879.
ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL
K111005 · Medica Corp. · Nov 2011
TECO DIAGNOSTICS SALIVA ALCOHOL TEST
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RANDOX ETHANOL ASSAY
K092273 · Randox Laboratories, Ltd. · Nov 2010
ETOH FLEX REAGENT CARTRIDGE (DF22)
K071811 · Dade Behring, Inc. · Aug 2007
DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022
K070853 · Dade Behring, Inc. · Jun 2007
DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI
K061792 · Dade Behring, Inc. · Jul 2006