Cleared Traditional

K111206 - TECO DIAGNOSTICS SALIVA ALCOHOL TEST

K111206 is an FDA 510(k) clearance for TECO DIAGNOSTICS SALIVA ALCOHOL TEST, manufactured by Teco Diagnostics. The device is a Class 2 Chemistry device with product code DIC cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K111206 · Teco Diagnostics · Chemistry device
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Oct 2011
Decision
158d
Days
Class 2
Risk

K111206 is an FDA 510(k) clearance for the TECO DIAGNOSTICS SALIVA ALCOHOL TEST. Classified as Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (product code DIC), Class II - Special Controls.

Submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on October 4, 2011 after a review of 158 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3040 - 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 Teco Diagnostics devices

FDA 510(k) Submission Details - K111206

510(k) Number K111206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2011
Decision Date October 04, 2011
Days to Decision 158 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 88d · This submission: 158d
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 Chemistry devices follow this clearance model.

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

All 26
Devices cleared under the same product code (DIC) and FDA review panel - the closest regulatory comparables to K111206.
Sober Self-Test
K250609 · Sober Ip, LLC · Sep 2025
Immunalysis Ethyl Alcohol Enzyme Assay
K181553 · Immunalysis Corporation · Oct 2018
ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL
K111005 · Medica Corp. · Nov 2011
RANDOX ETHANOL ASSAY
K092273 · Randox Laboratories, Ltd. · Nov 2010
MISSION SALIVA ALCOHOL TEST STRIP
K093879 · ACON Laboratories, Inc. · Aug 2010
ETOH FLEX REAGENT CARTRIDGE (DF22)
K071811 · Dade Behring, Inc. · Aug 2007